A multi-centre, prospective, observational pilot registry in patients undergoing mitralvalve repair for severe functional mitral regurgitation to report the heart failure drugtherapy and dosing before the mitral valve procedure and afterwards to assess whether therecommended maximal dose of medication is administered. This maximal dose, althoughrecommended, might not be tolerated well by patients and can cause side-effects.Researchers will determine whether the mitral valve repair procedure might have apossible 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:
- document the extent of suboptimal GDMT in patients undergoing M-TEER for severe FMR
and to assess the potential to improve care towards maximal recommended medical
therapy.
- compare 6- and 12-months heart failure (HF) hospitalization post-procedure compared
to 12- and 6-months historical HF hospitalisation prior the index procedure.
Functional status (NYHA class, 6-minute walk test) to be assessed at baseline and at
6 months follow-up.
Procedure: Mitral transcatheter edge-to-edge repair
Mitral transcatheter edge-to-edge repair with the PASCAL system
Other Name: M-TEER
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
Cellitinnen Hospital St. Vinzenz
Cologne, Nordrhein-Westfalen, Germany
Investigator: Jan-Malte Sinning, Prof.
Claudia M Lüske, PhD
+49 4471 8503324
claudia.lueske@ippmed.de
Marie F Zielinski
+49 4471 8503326
marie.zielinski@ippmed.de
Jan-Malte Sinning, Prof., Principal Investigator
Cellitinnen Hospital St. Vinzenz