Mitral Regurgitation Treatment in Advanced Heart Failure

MITRADVANCE-HF is a prospective, randomized, parallel-controlled, open-label, multicentre study trial enrolling patients with SMR and advanced HF on maximally tolerated standard of care therapies for HF according to the most recent guidelines. Enrolled patients will be randomly assigned, in a 1:1 ratio, to a device arm consisting of MitraClip therapy added to optimal medical therapy (OMT) or a control arm of OMT alone. Approximately 20 Italian high-volume centres will be involved. Enrolment duration will be of 24 months. Follow-up visit will be performed at 3, 6, and 12 months. Primary end-point was the absolute change in overall KCCQ summary score (KCCQ-OS) from baseline to 3 months follow-up.

NCT Number	NCT05292716
Lead Sponsor	Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Conditions	Heart Failure, Mitral Regurgitation
Enrollment	172 participants
Start Date	2021-04-21
Primary Completion	2025-04-21 (estimated)
Study Completion	2026-04-21 (estimated)
Updated on ClinicalTrials.gov	2024-08-05