NCT06702527

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

Optimizing Clinical Outcomes in Patients Undergoing M-TEER for Severe Functional Mitral Regurgitation Towards Improved Guideline-directed Medical Therapy - The MOTOR Registry

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Institut für Pharmakologie und Präventive Medizin · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mitral Regurgitation Functional
• Heart Failure
• M-TEER

Interventions

Type	Name	Description
PROCEDURE	Mitral transcatheter edge-to-edge repair	Mitral transcatheter edge-to-edge repair with the PASCAL system

Timeline

• Start date: 2025-06-01
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2024-11-25
• Last updated: 2025-05-23

Locations

1 site across 1 country: Germany