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Study aims to find best treatment for leaky heart valve in older adults

NCT ID NCT05825898

Disease control Sponsor: Ottawa Heart Institute Research Corporation 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at 3,500 people with severe tricuspid regurgitation, a common heart valve problem in older adults. It compares medical therapy (diuretics), surgery, and a less invasive transcatheter procedure to see which works best and when to treat. The goal is to improve survival and reduce heart failure hospitalizations.

What this could mean

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

Active substance
Surgery or transcatheter tricuspid valve intervention
What this could lead to
If successful, this could help doctors choose the best treatment and timing for patients with severe tricuspid regurgitation, potentially improving survival and reducing hospital visits.
What could go wrong
This is an observational study, not a randomized trial, so results may be influenced by patient differences. Surgery carries a high risk of in-hospital death (about 10%), and the study is still enrolling.

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.

Participants

About 3,500 people

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

Started

Sep 2022

Expected to finish

Dec 2026

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.

Who is studied

The investigators will enroll 3 populations of patients with isolated functional TR * Patients who remained under conservative management * Patients who underwent an isolated valve surgery * Patients who underwent a transcatheter valve intervention

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.

Inclusion Criteria: * Age ≥ 18 years * Isolated (no left-valvular heart disease (mitral regurgitation) \>2) * AND Functional * AND Moderate to severe or severe Tricuspid regurgitation Exclusion Criteria: * Congenital valvular disease, * Previous tricuspid valve intervention, * Organic tricuspid valvular disease * Associated valvular heart disease

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Conditions

The condition(s) this trial relates to.

tricuspid valve insufficiency

As listed by the trial registrant

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

Tricuspid regurgitation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    44 sites in 10 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • APHM, La Timone Hospital, Cardiology Department

    Marseille, France

  • Albertinen Heart and Vascular Center

    Hamburg, Germany

  • Amiens University Hospital

    Amiens, France

  • Asklepios clinic Sankt Georg

    Hamburg, Germany

  • Bonn University Hospital

    Bonn, Germany

  • CHU Charles Nicolle

    Rouen, France

  • CHU Lille

    Lille, France

  • CHU de Nantes

    Nantes, France

  • CHU de RENNES

    Rennes, France

  • Cardiology Department, Centre Cardiologique du Nord

    Saint-Denis, France

  • Cardiovascular center Frankfurt

    Frankfurt, Germany

  • Charité Universitätsmedizin Berlin

    Berlin, Germany

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Department of Cardiology, Bichat Claude Bernard Hospital

    Paris, France

  • Department of Cardiology, University Hospital of Nancy-Brabois

    Nancy, France

  • Department of Cardiovascular Surgery and Transplantation, Louis Pradel Cardiovascular Hospital

    Lyon, France

  • Henri Mondor Hospital

    Créteil, France

  • Herz- und Diabeteszentrum

    Bad Oeynhausen, Germany

  • Hopital Universitaire de Bern

    Bern, Switzerland

  • Hospital 12 de Octubre

    Madrid, Spain

  • Hospital Clínico San Carlos

    Madrid, Spain

  • Hospital Gregorio Marañón

    Madrid, Spain

  • Hospital Ramón y Cajal

    Madrid, Spain

  • IUCPQ

    Québec, Canada

  • Instituto Auxologico Italiano, IRCCS

    Milan, Italy

  • Istituto Cardiocentro Ticino

    Lugano, Switzerland

  • Leiden University Medical center

    Leiden, Netherlands

  • Leipzig University Hospital

    Leipzig, Germany

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905, United States

  • Montefiore Health System

    New York, New York, 10467, United States

  • Mount Sinai

    New York, New York, 10029, United States

  • Munich Großhadern

    Munich, Germany

  • Puerta de Hierro

    Madrid, Spain

  • Rangueil University Hospital

    Toulouse, France

  • San Raffaele University Hospital

    Milan, Italy

  • St Michael's Hospital

    Toronto, Canada

  • St Paul Hospital

    Vancouver, Canada

  • Tel Aviv Medical center

    Tel Aviv, Israel

  • University Heart and Vascular Center

    Hamburg, Germany

  • University Medical Center of Mainz

    Mainz, Germany

  • University of Cologne

    Cologne, Germany

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7, Canada

  • Vienna Medical University

    Vienna, Austria

  • Zurich Heart Center

    Zurich, Switzerland

More trials for these conditions

Other studies related to the condition(s) this trial covers.