Condition: Heart Failure · Mitral Regurgitation · Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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.
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| Marianna Adamo | Brescia, Lombardy, Italy | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05292716