An observational study in Mitral Regurgitation Functional, Heart Failure and M-TEER, sponsored by Institut für Pharmakologie und Präventive Medizin. Terminated at 2 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by Institut für Pharmakologie und Präventive Medizin · Observational
A multi-centre, prospective, observational pilot registry in patients undergoing mitral valve repair for severe functional mitral regurgitation to report the heart failure drug therapy and dosing before the mitral valve procedure and afterwards to assess whether the recommended maximal dose of medication is administered. This maximal dose, although recommended, might not be tolerated well by patients and can cause side-effects. Researchers will determine whether the mitral valve repair procedure might have a possible effect on increasing the drug therapy towards the recommended optimal doses.
Mitral transcatheter edge-to-edge repair (M-TEER) has become an important therapy in the management of severe functional mitral regurgitation (FMR).
These patients often have left ventricular dilatation with associated left ventricular failure and undergo intervention after guideline-directed medical therapy (GDMT) is optimised.
However, many patients cannot tolerate maximal doses of these drugs, some of which are potent vasodilators, due to the potential for hypotension and other side effects.
After M-TEER, with significant reduction of valve regurgitation, and a consequent improvement in systemic blood pressure and left ventricular function, it may be possible to further optimize GDMT and thus improve patients' clinical outcomes.
This pilot registry will be conducted in up to 4 German centres with a minimum annual volume of \~ 50 M-TEER procedures aiming for an environment of 100 patients.
This registry aims to:
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's enrollment of 9 is below the median of 200 across 1,983 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Institut für Pharmakologie und Präventive Medizin is the lead sponsor of 30 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with severe functional and mixed-type mitral regurgitation with optimized GMDT undergoing M-TEER (using the PASCAL system)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with optimized guideline-directed medical therapy (GDMT) undergoing mitral transcatheter edge-to-edge repair (M-TEER, using the PASCAL system) for severe functional mitral regurgitation.
Procedure: Mitral transcatheter edge-to-edge repair
Mitral transcatheter edge-to-edge repair with the PASCAL system
Also known as: M-TEER
Rate of Heart Failure hospitalizations after mitral transcatheter edge-to-edge repair (M-TEER)
Number of 6- and 12-months heart failure (HF) hospitalizations post M-TEER procedure compared to 12- and 6-months historical HF hospitalization prior the index procedure
Time frame: 6 and 12 months
New York Heart Association (NYHA) class
NYHA class at baseline and 6-months follow-up
Time frame: 6 months
6-minute walk test
6-minute walk test at baseline and 6-months follow-up
Time frame: 6 months
Plan to share: No — no IPD shared with other researchers, sponsor owns database
This study is terminated, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Institut für Pharmakologie und Präventive Medizin