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Heart valve repair may unlock higher doses of key heart failure drugs

NCT ID NCT07578129

Knowledge-focused Sponsor: Ceric Sàrl 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This observational study will follow 50 people with severe tricuspid regurgitation (a leaky heart valve) and reduced heart function who undergo valve repair using the PASCAL Precision System. The main goal is to see if, 12 months after repair, patients can take higher doses of standard heart failure medications compared to before the procedure. Researchers will also track hospitalizations and quality of life.

What this could mean

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

Active substance
PASCAL Precision System (device for tricuspid valve repair)
What this could lead to
If successful, this could show that repairing the tricuspid valve helps heart failure patients tolerate higher doses of guideline-directed medications, potentially improving outcomes.
What could go wrong
This is a small, early observational study (50 people) with no control group. It only measures medication changes, not direct health improvements, so results may not be conclusive.

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 50 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Participants from France with at least severe tricuspid regurgitation with associated left ventricular dysfunction

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: * Participants of age ≥ 18 years * ≥ severe tricuspid regurgitation * LVEF \< 50% * Written informed consent of the patient or her/his legal representative * Patient understands the purpose, the potential risks as well as benefits of the trial and is willing to participate in all parts of the follow-up * Planned follow-up within a dedicated heart failure clinic as part of routine care. Exclusion Criteria: * Anatomy unsuitable for TEER as determined by local heart team * severe mitral regurgitation (defined as an EROA\>40 mm2) treated (surgically or percutaneously) less than 3 months prior * severe left ventricular dysfunction (defined as an LVEF \<20%) * systolic pulmonary artery pressure \>70 mmHg (right heart catheterization) * prior tricuspid valve intervention * severe leaflet degeneration or tricuspid valve anatomy precluding successful device placement * primary tricuspid valve disease * COPD requiring home oxygen therapy * active endocarditis, or recent episode within 4 weeks of discontinuation of antibiotic therapy * participants with unstable hemodynamic condition * significant co-morbidities resulting in an expected less than 12-month life expectancy * The presence of other anatomic or comorbid conditions or other medical, social or psychological conditions that in the investigators' opinion could limit the subject's ability to participate in the clinical study and its follow-up. * Participants under judicial protection, guardianship or curatorship or if they are deprived of their liberty by judicial or administrative decision * Participation in another trial, which would lead to deviations in the preparation or performance of the intervention or the post-implantation management from this protocol

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Conditions

The condition(s) this trial relates to.

left ventricular failure tricuspid valve insufficiency Ventricular Dysfunction, Left

As listed by the trial registrant

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

Left ventricular (LV) systolic dysfunction Left ventricular cardiac dysfunction Left ventricular dysfunction Left ventricular ejection fraction Tricuspid insufficiency Tricuspid regurgitation (TR)

How to take part

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

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. 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.

More trials for these conditions

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