Acute Mitral Regurgitation
Conditions
Keywords
MitraClip
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).
Interventions
PROCEDUREEarly transcatheter edge-to-edge mitral valve repair (TEER).
TEER will be planned and performed as soon as possible, but within 60 days after index myocardial infarction, and within 30 days of randomisation using the MitraClip device.
DEVICEMitraClip
MitraClip
Optimal medical treatment
Sponsors
Meditrial Europe Ltd.
Fundación para la Investigación Biosanitaria del Principado de Asturias
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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) * EF ≤ 25% * Accepted for CABG * Presence of cardiogenic shock (AMR type 1)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause death or Cumulative Heart Failure hospitalizations | 12 months | Composite of 1. All-cause death 2. Cumulative Heart Failure hospitalizations |
Countries
Israel, Italy, Netherlands, Spain
Contacts
Primary ContactIsaac Pascual MD, PhD
Backup ContactPablo Avanzas, MD, PhD
Outcome results
None listed