Mitral Regurgitation Treatment in Advanced Heart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorAzienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
About this trial
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.
Eligibility criteria
Qualifiers
Age between 18 and 90 years
Significant secondary mitral regurgitation (effective regurgitant orifice area ≥ 5 30mm2) confirmed at the end of the screening period
Optimal medical therapy (OMT) according to recent guidelines.
Severe and persistent symptoms of HF (NYHA class III or IV)
Disqualifiers
Unfavorable mitral valve anatomy, which implanting investigator judges as not successfully treatable by the MitraClip (i.e. mitral valve area <3 mm2, leaflet length <7 mm)
Echocardiographic evidence of intracardiac mass, thrombus or vegetation
Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., noncompliant, perforated)
Active infections requiring current antibiotic therapy
Trial design
Treatments tested in this trial
- MitraClip
Treatment groups
172 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov