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New hope for heart failure: can a simple valve fix keep patients out of the hospital?

NCT ID NCT04634266

Disease control Sponsor: LMU Klinikum Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a minimally invasive procedure to repair a leaky tricuspid valve can help people with right-sided heart failure. About 360 participants will either receive the valve repair plus standard medications or medications alone. The goal is to see if the repair reduces deaths, hospitalizations, and improves quality of life over one year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
transcatheter tricuspid valve repair devices (annuloplasty or edge-to-edge repair)
What this could lead to
If successful, this could provide a proven treatment option to reduce hospitalizations and improve survival for people with severe tricuspid regurgitation and right-sided heart failure.
What could go wrong
This is a mid-stage trial with 360 participants, so results may not apply to all patients. The procedure carries risks like bleeding or device complications, and it is unclear if it will meaningfully improve survival.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 360 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2022

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

The following inclusion criteria were defined to assure generalizability of the population to be studied: * Subject is symptomatic due to severe TR despite being on stable OMT for at least 30 days based on judgment of the local heart team. * Subject is at intermediate or greater estimated risk of morbidity and mortality, defined as a) hospitalization for heart failure during the previous 12 months, or b) cardio-renal syndromea or c) cardio-hepatic syndrome * New York Heart Association (NYHA) Functional Class II, III or IVa * Femoral vein access and valve anatomy are determined to be feasible for interventional treatment (including sufficient quality of TTE and TEE imaging) * Age ≥ 18 years at time of consent * Subject must provide written informed consent prior to any trial related procedure The following exclusion criteria were selected to define a representative study cohort: * Presence of severe aortic, mitral or pulmonary valve disease OR surgical/interventional treatment at the aortic, mitral or pulmonary valves prior 60 days * Right heart catheterization (mandatory) with systolic pulmonary artery pressure \> 70 mmHg or substantial pre-capillary pulmonary hypertension (defined as mean pulmonary artery pressure (mPAP) \>30 mmHg plus transpulmonary gradient (TPG) \>17 mmHg or pulmonary vascular resistance (PVR) \>5 wood units) * Tricuspid valve stenosis (tricuspid mean gradient \> 5 mmHg) * Pacemaker or ICD leads that would prevent appropriate TTVT * Prior tricuspid valve procedures or tricuspid valve leaflet anatomy that would interfere with appropriate TTVT (e.g. calcification, Ebstein anomaly, coaptation defect \> 8mm for planned leaflet- and annuloplasty-based therapy) * Chronic renal failure requiring dialysis * Tricuspid valve anatomy not evaluable by TTE and TEE * Myocardial infarction or cerebrovascular accident within prior 90 days * Life expectancy of less than 12 months

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Conditions

The condition(s) this trial relates to.

heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart failure attributable to severe tricuspid regurgitation

Contacts and locations

Locations

  • Asklepios Klinikum St. Georg

    Hamburg, Germany

  • Charité Universitätsmedizin Berlin

    Berlin, Germany

  • Deutsches Herzzentrum Berlin

    Berlin, Germany

  • Helios Klinikum Erfurt

    Erfurt, Germany

  • Helios Klinikum Wuppertal

    Wuppertal, Germany

  • Herz- und Diabeteszentrum Nordrhein-Westfalen

    Bad Oeynhausen, Germany

  • Herzentrum Leipzig

    Leipzig, Germany

  • Herzzentrum Bremen

    Bremen, Germany

  • Herzzentrum Siegburg

    Siegburg, Germany

  • Herzzentrum UKE

    Hamburg, Germany

  • Herzzentrum Uniklinik Köln

    Cologne, Germany

  • Immanuel Klinikum Bernau Herzzentrum Brandenburg

    Bernau, Germany

  • Katholisches Marienkrankenhaus Hamburg

    Hamburg, Germany

  • LMU Klinikum

    München, Germany

  • Robert Bosch Klinikum Stuttgart

    Stuttgart, Germany

  • St.-Johannes-Hospital Dortmund

    Dortmund, Germany

  • Universitätsklinikum Bonn

    Bonn, Germany

  • Universitätsklinikum Düsseldorf

    Düsseldorf, Germany

  • Universitätsklinikum Essen

    Essen, Germany

  • Universitätsklinikum Frankfurt

    Frankfurt, Germany

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, Germany

  • Universitätsklinikum Heidelberg

    Heidelberg, Germany

  • Universitätsklinikum Jena

    Jena, Germany

  • Universitätsklinikum Schleswig-Holstein

    Kiel, Germany

  • Universitätsklinikum Schlewsig-Holstein Campus Lübeck

    Lübeck, Germany

  • Universitätsklinikum Tübingen

    Tübingen, Germany

  • Universitätsklinikum Ulm

    Ulm, Germany

  • Universitätsmedizin Mainz

    Mainz, Germany