Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
NCT05292716

Mitral Regurgitation Treatment in Advanced Heart Failure

Led by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · Updated on 2024-08-05

172

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Mitral Regurgitation Treatment in Advanced Heart Failure

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 90 years
  • Significant secondary mitral regurgitation confirmed at screening
  • Receiving optimal medical therapy according to recent guidelines
  • Advanced heart failure with severe and persistent symptoms (NYHA class III or IV) despite optimal therapy
  • Severe cardiac dysfunction with left ventricular ejection fraction 35% or less and/or high BNP or NTproBNP levels
  • Impaired quality of life (KCCQ score less than 75) and severe exercise limitation or recent unplanned heart failure hospitalization requiring intravenous treatment
Not Eligible

You will not qualify if you...

  • Unfavorable mitral valve anatomy judged unsuitable for MitraClip (e.g., valve area less than 3 mm2, leaflet length under 7 mm)
  • Presence of intracardiac mass, thrombus, or vegetation on echocardiogram
  • Active endocarditis, rheumatic heart disease, or rheumatic leaflet degeneration
  • Active infections requiring antibiotics
  • Contraindication or high risk for transesophageal echocardiography
  • Untreated significant coronary artery disease needing revascularization
  • Iron deficiency or recent intravenous iron treatment within 30 days before randomization
  • Recent coronary bypass, stent placement, valve replacement, or cardiac resynchronization therapy within 30 days
  • Recent pulmonary vein ablation, cardioversion, or AV node ablation within 30 days
  • Myocardial infarction or stroke within prior 30 days
  • Hemodynamic instability or need for inotropic or mechanical circulatory support
  • Chronic obstructive pulmonary disease, cancer, or other comorbidities causing severe symptoms and poor quality of life
  • Life expectancy less than 12 months due to non-cardiac causes

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Marianna Adamo

Brescia, Lombardy, Italy, 25123

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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