Optimizing Clinical Outcomes in Patients Undergoing Mitral Transcatheter Edge-to-edge Repair (M-TEER) for Severe Functional Mitral Regurgitation Towards Improved Guideline-directed Medical Therapy

Not yet recruiting

• Conditions: Mitral Regurgitation Functional; Heart Failure; M-TEER

• Registration Number: NCT06702527
• Lead Sponsor: Institut für Pharmakologie und Präventive Medizin

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-11-19
• Study First Submitted QC: 2024-11-21
• Study First Posted: 2024-11-25
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-23
• Study Start: 2025-06-01
• Primary Completion: 2026-09-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of Heart Failure hospitalizations after mitral transcatheter edge-to-edge repair (M-TEER)	6 and 12 months	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

Secondary Outcome Measures

Name	Time	Method
New York Heart Association (NYHA) class	6 months	NYHA class at baseline and 6-months follow-up
6-minute walk test	6 months	6-minute walk test at baseline and 6-months follow-up

Trial Locations

Locations (1)

Cellitinnen Hospital St. Vinzenz; 🇩🇪 Cologne, Nordrhein-Westfalen, Germany