Evidence map›Paper›PMID 40778456›Full record

Observational studyEuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology2025

Transcatheter valve repair of tricuspid regurgitation: 1-year outcomes from the TriCLASP study.

Stephan Baldus, Harald Lapp, Niklas Schofer, Tobias Geisler, Tobias Kister, Peter Lüdike, Tienush Rassaf, Jörg Hausleiter, Kai Friedrichs, Christian Frerker and 28 more

Registry-linked trialAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society 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 NCT07578129 (Improvement in Guideline-Directed Medical Therapy After Tricuspid Transcatheter Edge-to-Edge Repair in Participants With Reduced Left Ventricular Function), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing 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.

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
3 · Its place in the literature

Who cites it

9 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Review
  6. Article
  7. Transcatheter tricuspid valve treatment: a growing armamentarium of devices.European heart journal supplements : journal of the European Society of Cardiology · 2026
    Article
  8. Article
  9. The promise and pitfalls of registries for transcatheter tricuspid valve intervention.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2025
    Article
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

38 authors.

Stephan BaldusHerzzentrum Uniklinik Köln, Cologne, Germany.
Harald LappZentralklinik Bad Berka GmbH, Bad Berka, Germany.
Niklas SchoferUniversitätsklinikum Hamburg-Eppendorf, Hamburg, Germany.
Tobias GeislerUniversitätsklinikum Tübingen Innere Medizin III - Kardiologie und Angiologie, Tübingen, Germany.
Tobias KisterHerzzentrum Leipzig GmbH, Leipzig, Germany.
Peter LüdikeWestdeutsches Herz- und Gefäßzentrum Klinik für Kardiologie und Angiologie, Essen, Germany.
Tienush RassafWestdeutsches Herz- und Gefäßzentrum Klinik für Kardiologie und Angiologie, Essen, Germany.
Jörg HausleiterMedizinische Klinik I- Campus Großhadern, Munich, Germany.
Kai FriedrichsHerz- und Diabeteszentrum NRW, Bad Oeynhausen, Germany.
Christian FrerkerUniversitätsklinikum Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.
Edith LubosKath. Marienkrankenhaus, Hamburg, Germany.
Mirjam KesslerDepartment of Cardiology, Ulm University Heart Center, Ulm, Germany.
Konstantinos SpargiasHygeia Hospital, Athens, Greece.
Thomas SchmitzContilia Herz - und Gefäßzentrum, Elisabeth-Krankenhaus Essen, Essen, Germany.
Georg NickenigUniversitätsklinikum Bonn, Bonn, Germany.
Fabien PrazInselspital Universitätsspital Bern, Bern, Switzerland.
Sergio BertiOspedale del Cuore, Fondazione C.N.R. Reg. Toscana, Massa, Italy.
Claudia WaltherCardioangiologisches Centrum Bethanien, Frankfurt, Germany.
Dennis MehrkensHerzzentrum Uniklinik Köln, Cologne, Germany.
Bjorn GoebelZentralklinik Bad Berka GmbH, Bad Berka, Germany.
Daniel KalbacherUniversitätsklinikum Hamburg-Eppendorf, Hamburg, Germany.
Monika ZdanyteUniversitätsklinikum Tübingen Innere Medizin III - Kardiologie und Angiologie, Tübingen, Germany.
Maximilian von RoederHerzzentrum Leipzig GmbH, Leipzig, Germany.
Amir MahabadiWestdeutsches Herz- und Gefäßzentrum Klinik für Kardiologie und Angiologie, Essen, Germany.
Ludwig WeckbachMedizinische Klinik I- Campus Großhadern, Munich, Germany.
Maria IvannikovaHerz- und Diabeteszentrum NRW, Bad Oeynhausen, Germany.
Christoph MarquetandUniversitätsklinikum Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.
Inge DotzKath. Marienkrankenhaus, Hamburg, Germany.
Matthias GrögerDepartment of Cardiology, Ulm University Heart Center, Ulm, Germany.
Michael ChrissoherisHygeia Hospital, Athens, Greece.
Mareike EißmannContilia Herz - und Gefäßzentrum, Elisabeth-Krankenhaus Essen, Essen, Germany.
Johanna VogelhuberUniversitätsklinikum Bonn, Bonn, Germany.
Nicolas BruggerInselspital Universitätsspital Bern, Bern, Switzerland.
Andreina D'AgostinoOspedale del Cuore, Fondazione C.N.R. Reg. Toscana, Massa, Italy.
Manuela KrollCardioangiologisches Centrum Bethanien, Frankfurt, Germany.
Claire B RenCardialysis, Rotterdam, the Netherlands.
Philipp LurzHerzzentrum Leipzig GmbH, Leipzig, Germany.
On Behalf Of The TriCLASP Study Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients with tricuspid regurgitation (TR) are at high risk for morbidity and mortality, with poorer outcomes associated with increasing TR severity. Tricuspid transcatheter edge-to-edge repair (T-TEER) has emerged as a promising treatment option.

aimsTriCLASP is a prospective, single-arm, European post-market study evaluating the safety and effectiveness of T-TEER with the PASCAL system to treat patients with ≥severe TR.

methodsThe TriCLASP study enrolled 300 patients to evaluate the safety and performance of T-TEER. Major adverse events (MAE), reduction in TR grade, and clinical, functional, and quality-of-life outcomes were assessed at 1 year.

resultsEnrolled patients had a mean age of 80.1 years, 52.0% were female, and 75.8% had ≥severe TR. Tricuspid regurgitation was reduced to ≤moderate in 87.7% of patients (p<0.001). The composite MAE rate was 1.7% at 30 days and 12.7% at 1 year. Kaplan-Meier estimates for survival and freedom from heart failure hospitalisation (HFH) were 88.3±1.9% and 83.2±2.3%, respectively. Annualised HFH rates decreased by 72.2% in the 12 months pre- versus post-procedure (p<0.001). Significant functional and quality-of-life improvements were observed from baseline to 1 year, including 74.5% of patients in New York Heart Association Class I/II, a 29.4-metre increase in the 6-minute walk distance, and an 8.3-point increase in the Kansas City Cardiomyopathy Questionnaire score (p<0.001).

conclusionsThe 1-year results of the TriCLASP study confirm the safety and effectiveness of T-TEER with the PASCAL system in patients with ≥severe TR. Patients experienced significant TR reduction, low mortality, high freedom from HFH, and significant improvements in symptoms, functional capacity, and quality of life.

Indexed as

Cardiac CatheterizationHeart Valve Prosthesis ImplantationTricuspid ValveTricuspid Valve InsufficiencyAgedAged, 80 and overFemaleHeart Valve ProsthesisHumansMaleProduct Surveillance, PostmarketingProspective StudiesQuality of LifeTreatment Outcome

Identifiers

PMID40778456
PMCPMC12319578

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.