Early Transcatheter Mitral Valve Repair After Myocardial Infarction
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Mitral Regurgitation
- Sponsor
- Fundación para la Investigación Biosanitaria del Principado de Asturias
- Enrollment
- 250
- Locations
- 32
- Primary Endpoint
- All-cause death or Cumulative Heart Failure hospitalizations
- Status
- Recruiting
- Last Updated
- 6 months ago
Overview
Brief Summary
To explore the impact of early transcatheter edge-to-edge repair of acute functional mitral regurgitation after myocardial infarction on the combined incidence of death and heart-failure associated hospitalisations at one-year follow-up, and quality of life and LV remodelling at two-year follow-up.
Detailed Description
Prospective, multicentre, randomised, open-label, comparative effectiveness clinical trial for the treatment of clinically significant functional mitral regurgitation within 60 days after acute myocardial infarction, who are treated per standard of care and who have been determined by the site's local heart team as inappropriate or too high risk for mitral valve surgery. Eligible subjects will be randomized in a 1:1 ratio to the MitraClip device (intervention group) or to no MitraClip device (Control group).
Investigators
Isaac Pascual Calleja
MD, PhD
Fundación para la Investigación Biosanitaria del Principado de Asturias
Eligibility Criteria
Inclusion Criteria
- •Patients with symptomatic moderate to severe or severe MR after acute MI
- •Age \> 18 years
- •Based on the following classification recently published in "Transcatheter Mitral Edge-to-Edge Repair for Treatment of Acute Mitral Regurgitation" by M. Shuvy et al. (Can J Cardiol. 2023) patients will be included if categorized in Type 2, 3 or 4:
Exclusion Criteria
- •Primary MR (e.g. papillary muscle rupture)
- •Accepted for CABG
- •Presence of cardiogenic shock (AMR type 1)
Outcomes
Primary Outcomes
All-cause death or Cumulative Heart Failure hospitalizations
Time Frame: 12 months
Composite of 1. All-cause death 2. Cumulative Heart Failure hospitalizations