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 (MOTOR)

Institut für Pharmakologie und Präventive Medizin

Status: Not yet enrolling

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

Treatments: Procedure: Mitral transcatheter edge-to-edge repair

Study type: Observational

Funder types: NETWORK

Identifiers

NCT06702527

The MOTOR Registry

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

M-TEER patients

Description:

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.

Treatment:

Procedure: Mitral transcatheter edge-to-edge repair