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Heart valve repair may unlock better drug dosing for heart failure

NCT ID NCT06702527

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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This registry tracks people with severe functional mitral regurgitation and heart failure who undergo a minimally invasive mitral valve repair called M-TEER. The goal is to see whether the repair allows patients to tolerate higher, guideline-recommended doses of heart failure medications that often cause side effects. Researchers will compare hospitalizations and symptoms before and after the procedure.

What this could mean

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

Active substance
Mitral transcatheter edge-to-edge repair (M-TEER) with the PASCAL system
What this could lead to
If the procedure helps patients tolerate higher doses of heart failure medications, it could point toward a way to improve drug therapy and reduce hospitalizations.
What could go wrong
This is a small pilot registry with only 9 participants, so results may not apply broadly. The study is observational, meaning it cannot prove cause and effect.

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

9 people

The number who actually took part.

Started

Apr 2025

Finished

Mar 2026

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

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

Who is studied

Patients with severe functional and mixed-type mitral regurgitation with optimized GMDT undergoing M-TEER (using the PASCAL system)

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: * mitral transcatheter edge-to-edge repair (M-TEER) patients treated with the PASCAL system (≥ 18 years) as per the current approved indication and local Heart Team decision * Severe functional and mixed-type mitral regurgitation with LV-EF \< 50% * Patient with optimized guideline-directed medical therapy (GDMT): A minimum of 3 points in the pre-defined GMDT scoring system * Provision of written informed consent Exclusion Criteria: * Degenerative mitral regurgitation * Emergency procedure * Re-do or concomitant (mitral/tricuspid) procedures * Patients on maximum dose GDMT * Atrial functional mitral regurgitation (FMR) * Coronary revascularisation within the last 3 months * Pregnant woman

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Cellitinnen_Krankenhaus St. Vinzenz Köln

    Cologne, 50733, Germany

  • Krh der Barmherzigen Brüder Trier

    Trier, 54292, Germany

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