Evidence map›Paper›PMID 39570246›Full record

Trial reportJournal of the American College of Cardiology2025

Advanced Imaging Assessment of the Impact of Tricuspid Regurgitation on Cardiac Remodeling: The TRILUMINATE Pivotal Imaging Substudy.

João L Cavalcante, Markus Scherer, Miho Fukui, Stamatios Lerakis, Serge Harb, Amit Pursnani, Jonathan G Schwartz, Samir Kapadia, Mark J Ricciardi, Omar Khalique and 15 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the American College of Cardiology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03904147 (Clinical Trial to Evaluate Cardiovascular Outcomes In Patients Treated With the Tricuspid Valve Repair System Pivotal), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
–field-weighted citation impact
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
3 · Its place in the literature

Who cites it

11 citing papers in PubMed.

  1. Review
  2. Observational
  3. Review
  4. Worsening tricuspid regurgitation following a successful mitral valve procedure: how to manage.European heart journal supplements : journal of the European Society of Cardiology · 2026
    Article
  5. Advancement in pre- and peri-procedural imaging.European heart journal supplements : journal of the European Society of Cardiology · 2026
    Article
  6. Review
  7. Review
  8. Review
  9. Article
  10. Article
  11. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors.

João L CavalcanteAllina Health Minneapolis Heart Institute, Minneapolis, Minnesota, USA; Minneapolis Heart Institute Foundation Cardiovascular Imaging Research Center and Core Lab, Minneapolis, Minnesota, USA. Electronic address: joao.cavalcante@allina.com.
Markus SchererSanger Heart & Vascular Institute, Charlotte, North Carolina, USA.
Miho FukuiMinneapolis Heart Institute Foundation Cardiovascular Imaging Research Center and Core Lab, Minneapolis, Minnesota, USA.
Stamatios LerakisMount Sinai Hospital, New York, New York, USA.
Serge HarbThe Cleveland Clinic Foundation, Cleveland, Ohio, USA.
Amit PursnaniNorthShore University Health System, Evanston, Illinois, USA.
Jonathan G SchwartzAtrium Health Carolinas Medical Center, Charlotte, North Carolina, USA.
Samir KapadiaThe Cleveland Clinic Foundation, Cleveland, Ohio, USA.
Mark J RicciardiNorthShore University Health System, Evanston, Illinois, USA.
Omar KhaliqueNew York-Presbyterian/Columbia University Medical Center, New York, New York, USA.
Susheel KodaliNew York-Presbyterian/Columbia University Medical Center, New York, New York, USA.
Dipan ShahHouston Methodist Debakey Heart and Vascular Center, Houston, Texas, USA.
Steven H LittleHouston Methodist Debakey Heart and Vascular Center, Houston, Texas, USA.
Nishant SekaranIntermountain Medical Center, Murray, Utah, USA.
Brian WhisenantIntermountain Medical Center, Murray, Utah, USA.
Peter FlueckigerPiedmont Heart Institute, Atlanta, Georgia, USA.
Pradeep YadavPiedmont Heart Institute, Atlanta, Georgia, USA.
Abbas EmaminiaInova Heart and Vascular Institute, Fairfax, Virginia, USA.
Wayne BatchelorInova Heart and Vascular Institute, Fairfax, Virginia, USA.
Peter KellmanNational Institutes of Health, National Heart, Lung, and Blood Institute, Bethesda, Maryland, USA.
Zexu LinAbbott Structural Heart, Santa Clara, California, USA.
Phillip M TrustyAbbott Structural Heart, Santa Clara, California, USA.
Rebecca T HahnNew York-Presbyterian/Columbia University Medical Center, New York, New York, USA.
David AdamsMount Sinai Hospital, New York, New York, USA.
Paul SorajjaAllina Health Minneapolis Heart Institute, Minneapolis, Minnesota, USA.

Funding

Gadgetron Global Network and Artificial Intelligence Powered Cardiac ImagingZIAHL006242 · NHLBI · NATIONAL HEART, LUNG, AND BLOOD INSTITUTE · PI KELLMAN, PETER · 2019 to 2023
$2.2M
Intramural NIH HHS Z99 HL999999Intramural NIH HHS ZIA HL006242
6 · The paper itself

Abstract

backgroundThe impact of tricuspid regurgitation (TR) on cardiac remodeling has not been thoroughly studied in a randomized controlled trial using advanced imaging.

objectivesThe goal of this analysis was to provide comparative longitudinal changes in right heart remodeling using cardiac magnetic resonance and time-resolved functional computed tomography (4D-CT) in patients with symptomatic severe TR randomized to TriClip vs medical therapy (control).

methodsTRILUMINATE Pivotal (Clinical Trial to Evaluate Cardiovascular Outcomes In Patients Treated With the Tricuspid Valve Repair System Pivotal) is an international randomized controlled trial in symptomatic patients with severe TR. A prospective imaging substudy was performed on TRILUMINATE Pivotal subjects at 10 sites. Cardiac magnetic resonance and 4D-CT were performed following dedicated imaging protocols at baseline and at 30 days, and a final 4D-CT at 1 year (all assessed by an imaging core lab).

resultsSixty-nine randomized subjects (31 TriClip, 38 control) were enrolled. TR volume significantly decreased with TriClip at 30 days (P < 0.0001; 70% reduction). A strong association (r = 0.90; P < 0.0001) was observed between changes in TR volume and right ventricular end-diastolic volume at 30 days. Significant reductions in right ventricular end-diastolic volume (12% reduction; P < 0.001) and tricuspid annular area (11% reduction; P < 0.0001) were seen at 30 days and sustained through 1 year with TriClip. No meaningful changes were observed in the control group.

conclusionsAdvanced imaging from the TRILUMINATE Pivotal imaging substudy demonstrated that TriClip effectively reduced TR. Significant cardiac remodeling was observed at 30 days and sustained at 1 year. With TriClip, the extent of cardiac remodeling was associated with the degree of TR reduction. (Clinical Trial to Evaluate Cardiovascular Outcomes In Patients Treated With the Tricuspid Valve Repair System Pivotal; NCT03904147).

Indexed as

Tricuspid Valve InsufficiencyVentricular RemodelingAgedFemaleHumansMagnetic Resonance Imaging, CineMaleMiddle AgedProspective Studiescardiac computed tomographycardiac magnetic resonancecardiac remodelingtranscatheter edge-to-edge repairtricuspid regurgitation

Identifiers

PMID39570246
PMCPMC11956420

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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.