Heart valve repair may unlock better drug dosing for heart failure
NCT ID NCT06702527
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
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Mar 2026
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Cellitinnen_Krankenhaus St. Vinzenz Köln
Cologne, 50733, Germany
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Krh der Barmherzigen Brüder Trier
Trier, 54292, Germany
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