Evidence map›Paper›PMID 36876753›Full record

Trial reportThe New England journal of medicine2023

Transcatheter Repair for Patients with Tricuspid Regurgitation.

Paul Sorajja, Brian Whisenant, Nadira Hamid, Hursh Naik, Raj Makkar, Peter Tadros, Matthew J Price, Gagan Singh, Neil Fam, Saibal Kar and 17 more

3 registry-linked trialsAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 376 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
376citing papers in PubMed, 2 pooled it
171.0field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03904147 naactive not recruitingnot on this map

Clinical Trial to Evaluate Cardiovascular Outcomes In Patients Treated With the Tricuspid Valve Repair System Pivotal

TypeinterventionalSponsorAbbott Medical DevicesRan2019 to 2029Enrolled572ConditionsTricuspid RegurgitationArmsTriClipTM Device
NCT07578129 not yet recruitingnot on this mapstarted 2026, after this paper: background citation

Improvement in Guideline-Directed Medical Therapy After Tricuspid Transcatheter Edge-to-Edge Repair in Participants With Reduced Left Ventricular Function

Typeobservational_patient_registrySponsorCeric SàrlRan2026 to 2027Enrolled50ConditionsTricuspid Insufficiency, Tricuspid Regurgitation (TR), Left Ventricular Cardiac Dysfunction, Left Ventricular (LV) Systolic Dysfunction
NCT07623083 not yet recruitingnot on this mapstarted 2026, after this paper: background citation

Evaluation of a Treatment Algorithm for the Management of TAVI Patients With Significant Concomitant Mitral or Tricuspid Regurgitation

TypeobservationalSponsorJosep Rodes-CabauRan2026 to 2034Enrolled300ConditionsAortic Stenosis, Mitral Regurgitation, Tricuspid Regurgitation, Transcatheter Aortic Valve Implantation (TAVI)
3 · Its place in the literature

Who cites it

376 citing papers in PubMed, 2 syntheses or guidelines pooled it, 780 citations in OpenAlex.

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316 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

27 authors at 13 institutions in 4 countries.

Paul SorajjaFrom Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis (P.S., N.H., R. Bae); Intermountain Medical Center, Murray, UT (B.W., N.S.); St. Joseph's Hospital and Integrated Medical Services, Phoenix, AZ (H.N., T.W.); Cedars-Sinai Medical Center, Los Angeles (R.M., M.M.), Scripps Clinic Green Hospital, La Jolla (M.J.P.), UC Davis Medical Center, Sacramento (G.S.), Los Robles Regional Medical Center, Thousand Oaks (S.K.), and Abbott Structural Heart, Santa Clara (E.M.S., P.M.T.) - all in California; Kansas University Medical Center, Kansas City (P.T., G.Z.); St. Michael's Hospital, Toronto (N.F.), and McMaster University, Hamilton, ON (S.M.) - both in Canada; Carolinas Medical Center, Charlotte, NC (J.G.S.); Ohio State University, Columbus (R. Benza); Montefiore Medical Center, Bronx (U.J.), and Mount Sinai Health System (G.H.L.T., D.H.A.) and New York-Presbyterian Columbia University Medical Center (R.T.H.), New York - all in New York; Northwestern University, Chicago (P.M.); and Marcus Valve Center, Piedmont Heart Institute, Atlanta (V.T.).
Brian WhisenantFrom Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis (P.S., N.H., R. Bae); Intermountain Medical Center, Murray, UT (B.W., N.S.); St. Joseph's Hospital and Integrated Medical Services, Phoenix, AZ (H.N., T.W.); Cedars-Sinai Medical Center, Los Angeles (R.M., M.M.), Scripps Clinic Green Hospital, La Jolla (M.J.P.), UC Davis Medical Center, Sacramento (G.S.), Los Robles Regional Medical Center, Thousand Oaks (S.K.), and Abbott Structural Heart, Santa Clara (E.M.S., P.M.T.) - all in California; Kansas University Medical Center, Kansas City (P.T., G.Z.); St. Michael's Hospital, Toronto (N.F.), and McMaster University, Hamilton, ON (S.M.) - both in Canada; Carolinas Medical Center, Charlotte, NC (J.G.S.); Ohio State University, Columbus (R. Benza); Montefiore Medical Center, Bronx (U.J.), and Mount Sinai Health System (G.H.L.T., D.H.A.) and New York-Presbyterian Columbia University Medical Center (R.T.H.), New York - all in New York; Northwestern University, Chicago (P.M.); and Marcus Valve Center, Piedmont Heart Institute, Atlanta (V.T.).
Nadira HamidFrom Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis (P.S., N.H., R. Bae); Intermountain Medical Center, Murray, UT (B.W., N.S.); St. Joseph's Hospital and Integrated Medical Services, Phoenix, AZ (H.N., T.W.); Cedars-Sinai Medical Center, Los Angeles (R.M., M.M.), Scripps Clinic Green Hospital, La Jolla (M.J.P.), UC Davis Medical Center, Sacramento (G.S.), Los Robles Regional Medical Center, Thousand Oaks (S.K.), and Abbott Structural Heart, Santa Clara (E.M.S., P.M.T.) - all in California; Kansas University Medical Center, Kansas City (P.T., G.Z.); St. Michael's Hospital, Toronto (N.F.), and McMaster University, Hamilton, ON (S.M.) - both in Canada; Carolinas Medical Center, Charlotte, NC (J.G.S.); Ohio State University, Columbus (R. Benza); Montefiore Medical Center, Bronx (U.J.), and Mount Sinai Health System (G.H.L.T., D.H.A.) and New York-Presbyterian Columbia University Medical Center (R.T.H.), New York - all in New York; Northwestern University, Chicago (P.M.); and Marcus Valve Center, Piedmont Heart Institute, Atlanta (V.T.).
Hursh NaikFrom Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis (P.S., N.H., R. Bae); Intermountain Medical Center, Murray, UT (B.W., N.S.); St. Joseph's Hospital and Integrated Medical Services, Phoenix, AZ (H.N., T.W.); Cedars-Sinai Medical Center, Los Angeles (R.M., M.M.), Scripps Clinic Green Hospital, La Jolla (M.J.P.), UC Davis Medical Center, Sacramento (G.S.), Los Robles Regional Medical Center, Thousand Oaks (S.K.), and Abbott Structural Heart, Santa Clara (E.M.S., P.M.T.) - all in California; Kansas University Medical Center, Kansas City (P.T., G.Z.); St. Michael's Hospital, Toronto (N.F.), and McMaster University, Hamilton, ON (S.M.) - both in Canada; Carolinas Medical Center, Charlotte, NC (J.G.S.); Ohio State University, Columbus (R. Benza); Montefiore Medical Center, Bronx (U.J.), and Mount Sinai Health System (G.H.L.T., D.H.A.) and New York-Presbyterian Columbia University Medical Center (R.T.H.), New York - all in New York; Northwestern University, Chicago (P.M.); and Marcus Valve Center, Piedmont Heart Institute, Atlanta (V.T.).
Raj MakkarFrom Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis (P.S., N.H., R. Bae); Intermountain Medical Center, Murray, UT (B.W., N.S.); St. Joseph's Hospital and Integrated Medical Services, Phoenix, AZ (H.N., T.W.); Cedars-Sinai Medical Center, Los Angeles (R.M., M.M.), Scripps Clinic Green Hospital, La Jolla (M.J.P.), UC Davis Medical Center, Sacramento (G.S.), Los Robles Regional Medical Center, Thousand Oaks (S.K.), and Abbott Structural Heart, Santa Clara (E.M.S., P.M.T.) - all in California; Kansas University Medical Center, Kansas City (P.T., G.Z.); St. Michael's Hospital, Toronto (N.F.), and McMaster University, Hamilton, ON (S.M.) - both in Canada; Carolinas Medical Center, Charlotte, NC (J.G.S.); Ohio State University, Columbus (R. Benza); Montefiore Medical Center, Bronx (U.J.), and Mount Sinai Health System (G.H.L.T., D.H.A.) and New York-Presbyterian Columbia University Medical Center (R.T.H.), New York - all in New York; Northwestern University, Chicago (P.M.); and Marcus Valve Center, Piedmont Heart Institute, Atlanta (V.T.).
Peter TadrosFrom Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis (P.S., N.H., R. Bae); Intermountain Medical Center, Murray, UT (B.W., N.S.); St. Joseph's Hospital and Integrated Medical Services, Phoenix, AZ (H.N., T.W.); Cedars-Sinai Medical Center, Los Angeles (R.M., M.M.), Scripps Clinic Green Hospital, La Jolla (M.J.P.), UC Davis Medical Center, Sacramento (G.S.), Los Robles Regional Medical Center, Thousand Oaks (S.K.), and Abbott Structural Heart, Santa Clara (E.M.S., P.M.T.) - all in California; Kansas University Medical Center, Kansas City (P.T., G.Z.); St. Michael's Hospital, Toronto (N.F.), and McMaster University, Hamilton, ON (S.M.) - both in Canada; Carolinas Medical Center, Charlotte, NC (J.G.S.); Ohio State University, Columbus (R. Benza); Montefiore Medical Center, Bronx (U.J.), and Mount Sinai Health System (G.H.L.T., D.H.A.) and New York-Presbyterian Columbia University Medical Center (R.T.H.), New York - all in New York; Northwestern University, Chicago (P.M.); and Marcus Valve Center, Piedmont Heart Institute, Atlanta (V.T.).
Matthew J PriceFrom Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis (P.S., N.H., R. Bae); Intermountain Medical Center, Murray, UT (B.W., N.S.); St. Joseph's Hospital and Integrated Medical Services, Phoenix, AZ (H.N., T.W.); Cedars-Sinai Medical Center, Los Angeles (R.M., M.M.), Scripps Clinic Green Hospital, La Jolla (M.J.P.), UC Davis Medical Center, Sacramento (G.S.), Los Robles Regional Medical Center, Thousand Oaks (S.K.), and Abbott Structural Heart, Santa Clara (E.M.S., P.M.T.) - all in California; Kansas University Medical Center, Kansas City (P.T., G.Z.); St. Michael's Hospital, Toronto (N.F.), and McMaster University, Hamilton, ON (S.M.) - both in Canada; Carolinas Medical Center, Charlotte, NC (J.G.S.); Ohio State University, Columbus (R. Benza); Montefiore Medical Center, Bronx (U.J.), and Mount Sinai Health System (G.H.L.T., D.H.A.) and New York-Presbyterian Columbia University Medical Center (R.T.H.), New York - all in New York; Northwestern University, Chicago (P.M.); and Marcus Valve Center, Piedmont Heart Institute, Atlanta (V.T.).
Gagan SinghFrom Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis (P.S., N.H., R. Bae); Intermountain Medical Center, Murray, UT (B.W., N.S.); St. Joseph's Hospital and Integrated Medical Services, Phoenix, AZ (H.N., T.W.); Cedars-Sinai Medical Center, Los Angeles (R.M., M.M.), Scripps Clinic Green Hospital, La Jolla (M.J.P.), UC Davis Medical Center, Sacramento (G.S.), Los Robles Regional Medical Center, Thousand Oaks (S.K.), and Abbott Structural Heart, Santa Clara (E.M.S., P.M.T.) - all in California; Kansas University Medical Center, Kansas City (P.T., G.Z.); St. Michael's Hospital, Toronto (N.F.), and McMaster University, Hamilton, ON (S.M.) - both in Canada; Carolinas Medical Center, Charlotte, NC (J.G.S.); Ohio State University, Columbus (R. Benza); Montefiore Medical Center, Bronx (U.J.), and Mount Sinai Health System (G.H.L.T., D.H.A.) and New York-Presbyterian Columbia University Medical Center (R.T.H.), New York - all in New York; Northwestern University, Chicago (P.M.); and Marcus Valve Center, Piedmont Heart Institute, Atlanta (V.T.).
Neil FamFrom Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis (P.S., N.H., R. Bae); Intermountain Medical Center, Murray, UT (B.W., N.S.); St. Joseph's Hospital and Integrated Medical Services, Phoenix, AZ (H.N., T.W.); Cedars-Sinai Medical Center, Los Angeles (R.M., M.M.), Scripps Clinic Green Hospital, La Jolla (M.J.P.), UC Davis Medical Center, Sacramento (G.S.), Los Robles Regional Medical Center, Thousand Oaks (S.K.), and Abbott Structural Heart, Santa Clara (E.M.S., P.M.T.) - all in California; Kansas University Medical Center, Kansas City (P.T., G.Z.); St. Michael's Hospital, Toronto (N.F.), and McMaster University, Hamilton, ON (S.M.) - both in Canada; Carolinas Medical Center, Charlotte, NC (J.G.S.); Ohio State University, Columbus (R. Benza); Montefiore Medical Center, Bronx (U.J.), and Mount Sinai Health System (G.H.L.T., D.H.A.) and New York-Presbyterian Columbia University Medical Center (R.T.H.), New York - all in New York; Northwestern University, Chicago (P.M.); and Marcus Valve Center, Piedmont Heart Institute, Atlanta (V.T.).
Saibal KarFrom Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis (P.S., N.H., R. Bae); Intermountain Medical Center, Murray, UT (B.W., N.S.); St. Joseph's Hospital and Integrated Medical Services, Phoenix, AZ (H.N., T.W.); Cedars-Sinai Medical Center, Los Angeles (R.M., M.M.), Scripps Clinic Green Hospital, La Jolla (M.J.P.), UC Davis Medical Center, Sacramento (G.S.), Los Robles Regional Medical Center, Thousand Oaks (S.K.), and Abbott Structural Heart, Santa Clara (E.M.S., P.M.T.) - all in California; Kansas University Medical Center, Kansas City (P.T., G.Z.); St. Michael's Hospital, Toronto (N.F.), and McMaster University, Hamilton, ON (S.M.) - both in Canada; Carolinas Medical Center, Charlotte, NC (J.G.S.); Ohio State University, Columbus (R. Benza); Montefiore Medical Center, Bronx (U.J.), and Mount Sinai Health System (G.H.L.T., D.H.A.) and New York-Presbyterian Columbia University Medical Center (R.T.H.), New York - all in New York; Northwestern University, Chicago (P.M.); and Marcus Valve Center, Piedmont Heart Institute, Atlanta (V.T.).
Jonathan G SchwartzFrom Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis (P.S., N.H., R. Bae); Intermountain Medical Center, Murray, UT (B.W., N.S.); St. Joseph's Hospital and Integrated Medical Services, Phoenix, AZ (H.N., T.W.); Cedars-Sinai Medical Center, Los Angeles (R.M., M.M.), Scripps Clinic Green Hospital, La Jolla (M.J.P.), UC Davis Medical Center, Sacramento (G.S.), Los Robles Regional Medical Center, Thousand Oaks (S.K.), and Abbott Structural Heart, Santa Clara (E.M.S., P.M.T.) - all in California; Kansas University Medical Center, Kansas City (P.T., G.Z.); St. Michael's Hospital, Toronto (N.F.), and McMaster University, Hamilton, ON (S.M.) - both in Canada; Carolinas Medical Center, Charlotte, NC (J.G.S.); Ohio State University, Columbus (R. Benza); Montefiore Medical Center, Bronx (U.J.), and Mount Sinai Health System (G.H.L.T., D.H.A.) and New York-Presbyterian Columbia University Medical Center (R.T.H.), New York - all in New York; Northwestern University, Chicago (P.M.); and Marcus Valve Center, Piedmont Heart Institute, Atlanta (V.T.).
Shamir MehtaFrom Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis (P.S., N.H., R. Bae); Intermountain Medical Center, Murray, UT (B.W., N.S.); St. Joseph's Hospital and Integrated Medical Services, Phoenix, AZ (H.N., T.W.); Cedars-Sinai Medical Center, Los Angeles (R.M., M.M.), Scripps Clinic Green Hospital, La Jolla (M.J.P.), UC Davis Medical Center, Sacramento (G.S.), Los Robles Regional Medical Center, Thousand Oaks (S.K.), and Abbott Structural Heart, Santa Clara (E.M.S., P.M.T.) - all in California; Kansas University Medical Center, Kansas City (P.T., G.Z.); St. Michael's Hospital, Toronto (N.F.), and McMaster University, Hamilton, ON (S.M.) - both in Canada; Carolinas Medical Center, Charlotte, NC (J.G.S.); Ohio State University, Columbus (R. Benza); Montefiore Medical Center, Bronx (U.J.), and Mount Sinai Health System (G.H.L.T., D.H.A.) and New York-Presbyterian Columbia University Medical Center (R.T.H.), New York - all in New York; Northwestern University, Chicago (P.M.); and Marcus Valve Center, Piedmont Heart Institute, Atlanta (V.T.).
Richard BaeFrom Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis (P.S., N.H., R. Bae); Intermountain Medical Center, Murray, UT (B.W., N.S.); St. Joseph's Hospital and Integrated Medical Services, Phoenix, AZ (H.N., T.W.); Cedars-Sinai Medical Center, Los Angeles (R.M., M.M.), Scripps Clinic Green Hospital, La Jolla (M.J.P.), UC Davis Medical Center, Sacramento (G.S.), Los Robles Regional Medical Center, Thousand Oaks (S.K.), and Abbott Structural Heart, Santa Clara (E.M.S., P.M.T.) - all in California; Kansas University Medical Center, Kansas City (P.T., G.Z.); St. Michael's Hospital, Toronto (N.F.), and McMaster University, Hamilton, ON (S.M.) - both in Canada; Carolinas Medical Center, Charlotte, NC (J.G.S.); Ohio State University, Columbus (R. Benza); Montefiore Medical Center, Bronx (U.J.), and Mount Sinai Health System (G.H.L.T., D.H.A.) and New York-Presbyterian Columbia University Medical Center (R.T.H.), New York - all in New York; Northwestern University, Chicago (P.M.); and Marcus Valve Center, Piedmont Heart Institute, Atlanta (V.T.).
Nishant SekaranFrom Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis (P.S., N.H., R. Bae); Intermountain Medical Center, Murray, UT (B.W., N.S.); St. Joseph's Hospital and Integrated Medical Services, Phoenix, AZ (H.N., T.W.); Cedars-Sinai Medical Center, Los Angeles (R.M., M.M.), Scripps Clinic Green Hospital, La Jolla (M.J.P.), UC Davis Medical Center, Sacramento (G.S.), Los Robles Regional Medical Center, Thousand Oaks (S.K.), and Abbott Structural Heart, Santa Clara (E.M.S., P.M.T.) - all in California; Kansas University Medical Center, Kansas City (P.T., G.Z.); St. Michael's Hospital, Toronto (N.F.), and McMaster University, Hamilton, ON (S.M.) - both in Canada; Carolinas Medical Center, Charlotte, NC (J.G.S.); Ohio State University, Columbus (R. Benza); Montefiore Medical Center, Bronx (U.J.), and Mount Sinai Health System (G.H.L.T., D.H.A.) and New York-Presbyterian Columbia University Medical Center (R.T.H.), New York - all in New York; Northwestern University, Chicago (P.M.); and Marcus Valve Center, Piedmont Heart Institute, Atlanta (V.T.).
Travis WarnerFrom Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis (P.S., N.H., R. Bae); Intermountain Medical Center, Murray, UT (B.W., N.S.); St. Joseph's Hospital and Integrated Medical Services, Phoenix, AZ (H.N., T.W.); Cedars-Sinai Medical Center, Los Angeles (R.M., M.M.), Scripps Clinic Green Hospital, La Jolla (M.J.P.), UC Davis Medical Center, Sacramento (G.S.), Los Robles Regional Medical Center, Thousand Oaks (S.K.), and Abbott Structural Heart, Santa Clara (E.M.S., P.M.T.) - all in California; Kansas University Medical Center, Kansas City (P.T., G.Z.); St. Michael's Hospital, Toronto (N.F.), and McMaster University, Hamilton, ON (S.M.) - both in Canada; Carolinas Medical Center, Charlotte, NC (J.G.S.); Ohio State University, Columbus (R. Benza); Montefiore Medical Center, Bronx (U.J.), and Mount Sinai Health System (G.H.L.T., D.H.A.) and New York-Presbyterian Columbia University Medical Center (R.T.H.), New York - all in New York; Northwestern University, Chicago (P.M.); and Marcus Valve Center, Piedmont Heart Institute, Atlanta (V.T.).
Moody MakarFrom Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis (P.S., N.H., R. Bae); Intermountain Medical Center, Murray, UT (B.W., N.S.); St. Joseph's Hospital and Integrated Medical Services, Phoenix, AZ (H.N., T.W.); Cedars-Sinai Medical Center, Los Angeles (R.M., M.M.), Scripps Clinic Green Hospital, La Jolla (M.J.P.), UC Davis Medical Center, Sacramento (G.S.), Los Robles Regional Medical Center, Thousand Oaks (S.K.), and Abbott Structural Heart, Santa Clara (E.M.S., P.M.T.) - all in California; Kansas University Medical Center, Kansas City (P.T., G.Z.); St. Michael's Hospital, Toronto (N.F.), and McMaster University, Hamilton, ON (S.M.) - both in Canada; Carolinas Medical Center, Charlotte, NC (J.G.S.); Ohio State University, Columbus (R. Benza); Montefiore Medical Center, Bronx (U.J.), and Mount Sinai Health System (G.H.L.T., D.H.A.) and New York-Presbyterian Columbia University Medical Center (R.T.H.), New York - all in New York; Northwestern University, Chicago (P.M.); and Marcus Valve Center, Piedmont Heart Institute, Atlanta (V.T.).
George ZornFrom Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis (P.S., N.H., R. Bae); Intermountain Medical Center, Murray, UT (B.W., N.S.); St. Joseph's Hospital and Integrated Medical Services, Phoenix, AZ (H.N., T.W.); Cedars-Sinai Medical Center, Los Angeles (R.M., M.M.), Scripps Clinic Green Hospital, La Jolla (M.J.P.), UC Davis Medical Center, Sacramento (G.S.), Los Robles Regional Medical Center, Thousand Oaks (S.K.), and Abbott Structural Heart, Santa Clara (E.M.S., P.M.T.) - all in California; Kansas University Medical Center, Kansas City (P.T., G.Z.); St. Michael's Hospital, Toronto (N.F.), and McMaster University, Hamilton, ON (S.M.) - both in Canada; Carolinas Medical Center, Charlotte, NC (J.G.S.); Ohio State University, Columbus (R. Benza); Montefiore Medical Center, Bronx (U.J.), and Mount Sinai Health System (G.H.L.T., D.H.A.) and New York-Presbyterian Columbia University Medical Center (R.T.H.), New York - all in New York; Northwestern University, Chicago (P.M.); and Marcus Valve Center, Piedmont Heart Institute, Atlanta (V.T.).
Erin M SpinnerFrom Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis (P.S., N.H., R. Bae); Intermountain Medical Center, Murray, UT (B.W., N.S.); St. Joseph's Hospital and Integrated Medical Services, Phoenix, AZ (H.N., T.W.); Cedars-Sinai Medical Center, Los Angeles (R.M., M.M.), Scripps Clinic Green Hospital, La Jolla (M.J.P.), UC Davis Medical Center, Sacramento (G.S.), Los Robles Regional Medical Center, Thousand Oaks (S.K.), and Abbott Structural Heart, Santa Clara (E.M.S., P.M.T.) - all in California; Kansas University Medical Center, Kansas City (P.T., G.Z.); St. Michael's Hospital, Toronto (N.F.), and McMaster University, Hamilton, ON (S.M.) - both in Canada; Carolinas Medical Center, Charlotte, NC (J.G.S.); Ohio State University, Columbus (R. Benza); Montefiore Medical Center, Bronx (U.J.), and Mount Sinai Health System (G.H.L.T., D.H.A.) and New York-Presbyterian Columbia University Medical Center (R.T.H.), New York - all in New York; Northwestern University, Chicago (P.M.); and Marcus Valve Center, Piedmont Heart Institute, Atlanta (V.T.).
Phillip M TrustyFrom Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis (P.S., N.H., R. Bae); Intermountain Medical Center, Murray, UT (B.W., N.S.); St. Joseph's Hospital and Integrated Medical Services, Phoenix, AZ (H.N., T.W.); Cedars-Sinai Medical Center, Los Angeles (R.M., M.M.), Scripps Clinic Green Hospital, La Jolla (M.J.P.), UC Davis Medical Center, Sacramento (G.S.), Los Robles Regional Medical Center, Thousand Oaks (S.K.), and Abbott Structural Heart, Santa Clara (E.M.S., P.M.T.) - all in California; Kansas University Medical Center, Kansas City (P.T., G.Z.); St. Michael's Hospital, Toronto (N.F.), and McMaster University, Hamilton, ON (S.M.) - both in Canada; Carolinas Medical Center, Charlotte, NC (J.G.S.); Ohio State University, Columbus (R. Benza); Montefiore Medical Center, Bronx (U.J.), and Mount Sinai Health System (G.H.L.T., D.H.A.) and New York-Presbyterian Columbia University Medical Center (R.T.H.), New York - all in New York; Northwestern University, Chicago (P.M.); and Marcus Valve Center, Piedmont Heart Institute, Atlanta (V.T.).
Raymond BenzaFrom Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis (P.S., N.H., R. Bae); Intermountain Medical Center, Murray, UT (B.W., N.S.); St. Joseph's Hospital and Integrated Medical Services, Phoenix, AZ (H.N., T.W.); Cedars-Sinai Medical Center, Los Angeles (R.M., M.M.), Scripps Clinic Green Hospital, La Jolla (M.J.P.), UC Davis Medical Center, Sacramento (G.S.), Los Robles Regional Medical Center, Thousand Oaks (S.K.), and Abbott Structural Heart, Santa Clara (E.M.S., P.M.T.) - all in California; Kansas University Medical Center, Kansas City (P.T., G.Z.); St. Michael's Hospital, Toronto (N.F.), and McMaster University, Hamilton, ON (S.M.) - both in Canada; Carolinas Medical Center, Charlotte, NC (J.G.S.); Ohio State University, Columbus (R. Benza); Montefiore Medical Center, Bronx (U.J.), and Mount Sinai Health System (G.H.L.T., D.H.A.) and New York-Presbyterian Columbia University Medical Center (R.T.H.), New York - all in New York; Northwestern University, Chicago (P.M.); and Marcus Valve Center, Piedmont Heart Institute, Atlanta (V.T.).
Ulrich JordeFrom Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis (P.S., N.H., R. Bae); Intermountain Medical Center, Murray, UT (B.W., N.S.); St. Joseph's Hospital and Integrated Medical Services, Phoenix, AZ (H.N., T.W.); Cedars-Sinai Medical Center, Los Angeles (R.M., M.M.), Scripps Clinic Green Hospital, La Jolla (M.J.P.), UC Davis Medical Center, Sacramento (G.S.), Los Robles Regional Medical Center, Thousand Oaks (S.K.), and Abbott Structural Heart, Santa Clara (E.M.S., P.M.T.) - all in California; Kansas University Medical Center, Kansas City (P.T., G.Z.); St. Michael's Hospital, Toronto (N.F.), and McMaster University, Hamilton, ON (S.M.) - both in Canada; Carolinas Medical Center, Charlotte, NC (J.G.S.); Ohio State University, Columbus (R. Benza); Montefiore Medical Center, Bronx (U.J.), and Mount Sinai Health System (G.H.L.T., D.H.A.) and New York-Presbyterian Columbia University Medical Center (R.T.H.), New York - all in New York; Northwestern University, Chicago (P.M.); and Marcus Valve Center, Piedmont Heart Institute, Atlanta (V.T.).
Patrick McCarthyFrom Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis (P.S., N.H., R. Bae); Intermountain Medical Center, Murray, UT (B.W., N.S.); St. Joseph's Hospital and Integrated Medical Services, Phoenix, AZ (H.N., T.W.); Cedars-Sinai Medical Center, Los Angeles (R.M., M.M.), Scripps Clinic Green Hospital, La Jolla (M.J.P.), UC Davis Medical Center, Sacramento (G.S.), Los Robles Regional Medical Center, Thousand Oaks (S.K.), and Abbott Structural Heart, Santa Clara (E.M.S., P.M.T.) - all in California; Kansas University Medical Center, Kansas City (P.T., G.Z.); St. Michael's Hospital, Toronto (N.F.), and McMaster University, Hamilton, ON (S.M.) - both in Canada; Carolinas Medical Center, Charlotte, NC (J.G.S.); Ohio State University, Columbus (R. Benza); Montefiore Medical Center, Bronx (U.J.), and Mount Sinai Health System (G.H.L.T., D.H.A.) and New York-Presbyterian Columbia University Medical Center (R.T.H.), New York - all in New York; Northwestern University, Chicago (P.M.); and Marcus Valve Center, Piedmont Heart Institute, Atlanta (V.T.).
Vinod ThouraniFrom Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis (P.S., N.H., R. Bae); Intermountain Medical Center, Murray, UT (B.W., N.S.); St. Joseph's Hospital and Integrated Medical Services, Phoenix, AZ (H.N., T.W.); Cedars-Sinai Medical Center, Los Angeles (R.M., M.M.), Scripps Clinic Green Hospital, La Jolla (M.J.P.), UC Davis Medical Center, Sacramento (G.S.), Los Robles Regional Medical Center, Thousand Oaks (S.K.), and Abbott Structural Heart, Santa Clara (E.M.S., P.M.T.) - all in California; Kansas University Medical Center, Kansas City (P.T., G.Z.); St. Michael's Hospital, Toronto (N.F.), and McMaster University, Hamilton, ON (S.M.) - both in Canada; Carolinas Medical Center, Charlotte, NC (J.G.S.); Ohio State University, Columbus (R. Benza); Montefiore Medical Center, Bronx (U.J.), and Mount Sinai Health System (G.H.L.T., D.H.A.) and New York-Presbyterian Columbia University Medical Center (R.T.H.), New York - all in New York; Northwestern University, Chicago (P.M.); and Marcus Valve Center, Piedmont Heart Institute, Atlanta (V.T.).
Gilbert H L TangFrom Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis (P.S., N.H., R. Bae); Intermountain Medical Center, Murray, UT (B.W., N.S.); St. Joseph's Hospital and Integrated Medical Services, Phoenix, AZ (H.N., T.W.); Cedars-Sinai Medical Center, Los Angeles (R.M., M.M.), Scripps Clinic Green Hospital, La Jolla (M.J.P.), UC Davis Medical Center, Sacramento (G.S.), Los Robles Regional Medical Center, Thousand Oaks (S.K.), and Abbott Structural Heart, Santa Clara (E.M.S., P.M.T.) - all in California; Kansas University Medical Center, Kansas City (P.T., G.Z.); St. Michael's Hospital, Toronto (N.F.), and McMaster University, Hamilton, ON (S.M.) - both in Canada; Carolinas Medical Center, Charlotte, NC (J.G.S.); Ohio State University, Columbus (R. Benza); Montefiore Medical Center, Bronx (U.J.), and Mount Sinai Health System (G.H.L.T., D.H.A.) and New York-Presbyterian Columbia University Medical Center (R.T.H.), New York - all in New York; Northwestern University, Chicago (P.M.); and Marcus Valve Center, Piedmont Heart Institute, Atlanta (V.T.).
Rebecca T HahnFrom Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis (P.S., N.H., R. Bae); Intermountain Medical Center, Murray, UT (B.W., N.S.); St. Joseph's Hospital and Integrated Medical Services, Phoenix, AZ (H.N., T.W.); Cedars-Sinai Medical Center, Los Angeles (R.M., M.M.), Scripps Clinic Green Hospital, La Jolla (M.J.P.), UC Davis Medical Center, Sacramento (G.S.), Los Robles Regional Medical Center, Thousand Oaks (S.K.), and Abbott Structural Heart, Santa Clara (E.M.S., P.M.T.) - all in California; Kansas University Medical Center, Kansas City (P.T., G.Z.); St. Michael's Hospital, Toronto (N.F.), and McMaster University, Hamilton, ON (S.M.) - both in Canada; Carolinas Medical Center, Charlotte, NC (J.G.S.); Ohio State University, Columbus (R. Benza); Montefiore Medical Center, Bronx (U.J.), and Mount Sinai Health System (G.H.L.T., D.H.A.) and New York-Presbyterian Columbia University Medical Center (R.T.H.), New York - all in New York; Northwestern University, Chicago (P.M.); and Marcus Valve Center, Piedmont Heart Institute, Atlanta (V.T.).
David H AdamsFrom Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis (P.S., N.H., R. Bae); Intermountain Medical Center, Murray, UT (B.W., N.S.); St. Joseph's Hospital and Integrated Medical Services, Phoenix, AZ (H.N., T.W.); Cedars-Sinai Medical Center, Los Angeles (R.M., M.M.), Scripps Clinic Green Hospital, La Jolla (M.J.P.), UC Davis Medical Center, Sacramento (G.S.), Los Robles Regional Medical Center, Thousand Oaks (S.K.), and Abbott Structural Heart, Santa Clara (E.M.S., P.M.T.) - all in California; Kansas University Medical Center, Kansas City (P.T., G.Z.); St. Michael's Hospital, Toronto (N.F.), and McMaster University, Hamilton, ON (S.M.) - both in Canada; Carolinas Medical Center, Charlotte, NC (J.G.S.); Ohio State University, Columbus (R. Benza); Montefiore Medical Center, Bronx (U.J.), and Mount Sinai Health System (G.H.L.T., D.H.A.) and New York-Presbyterian Columbia University Medical Center (R.T.H.), New York - all in New York; Northwestern University, Chicago (P.M.); and Marcus Valve Center, Piedmont Heart Institute, Atlanta (V.T.).
TRILUMINATE Pivotal Investigators
St. Joseph's Hospital and Medical Center · USCedars-Sinai Medical Center · USMount Sinai Health System · USAbbott (Canada) · CAAllina Health · USCarolinas Medical Center · USColumbia University Irving Medical Center · USLos Robles Hospital & Medical Center · USMcMaster University · CAMontefiore Medical Center · USNorthwestern University · PHUniversity Medical Center · USUniversity of California Davis Medical Center · US

Funding

Abbott
6 · The paper itself

Abstract

backgroundSevere tricuspid regurgitation is a debilitating condition that is associated with substantial morbidity and often with poor quality of life. Decreasing tricuspid regurgitation may reduce symptoms and improve clinical outcomes in patients with this disease.

methodsWe conducted a prospective randomized trial of percutaneous tricuspid transcatheter edge-to-edge repair (TEER) for severe tricuspid regurgitation. Patients with symptomatic severe tricuspid regurgitation were enrolled at 65 centers in the United States, Canada, and Europe and were randomly assigned in a 1:1 ratio to receive either TEER or medical therapy (control). The primary end point was a hierarchical composite that included death from any cause or tricuspid-valve surgery; hospitalization for heart failure; and an improvement in quality of life as measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ), with an improvement defined as an increase of at least 15 points in the KCCQ score (range, 0 to 100, with higher scores indicating better quality of life) at the 1-year follow-up. The severity of tricuspid regurgitation and safety were also assessed.

resultsA total of 350 patients were enrolled; 175 were assigned to each group. The mean age of the patients was 78 years, and 54.9% were women. The results for the primary end point favored the TEER group (win ratio, 1.48; 95% confidence interval, 1.06 to 2.13; P = 0.02). The incidence of death or tricuspid-valve surgery and the rate of hospitalization for heart failure did not appear to differ between the groups. The KCCQ quality-of-life score changed by a mean (±SD) of 12.3±1.8 points in the TEER group, as compared with 0.6±1.8 points in the control group (P<0.001). At 30 days, 87.0% of the patients in the TEER group and 4.8% of those in the control group had tricuspid regurgitation of no greater than moderate severity (P<0.001). TEER was found to be safe; 98.3% of the patients who underwent the procedure were free from major adverse events at 30 days.

conclusionsTricuspid TEER was safe for patients with severe tricuspid regurgitation, reduced the severity of tricuspid regurgitation, and was associated with an improvement in quality of life. (Funded by Abbott; TRILUMINATE Pivotal ClinicalTrials.gov number, NCT03904147.).

Indexed as

Heart Valve Prosthesis ImplantationTricuspid Valve InsufficiencyAgedCardiac CatheterizationFemaleHeart FailureHumansMaleProspective StudiesQuality of LifeTreatment Outcome

Identifiers

PMID36876753
OpenAlexW4323076139

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.