Early Transcatheter Mitral Valve Repair After Myocardial Infarction
NCT06282042 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250
Last updated 2025-10-17
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.
Conditions
- Acute Mitral Regurgitation
Interventions
- PROCEDURE
-
Early 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.
- DEVICE
-
MitraClip
MitraClip
- OTHER
-
Optimal medical treatment
Optimal medical treatment
Sponsors & Collaborators
-
Meditrial Europe Ltd.
collaborator INDUSTRY -
Fundación para la Investigación Biosanitaria del Principado de Asturias
lead OTHER
Principal Investigators
-
Isaac Pascual, MD, PhD · Hospital Universitario Central de Asturias
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-12-24
- Primary Completion
- 2027-06-16
- Completion
- 2028-06-16
- FDA Device
- Yes
Countries
- Israel
- Italy
- Netherlands
- Spain
Study Locations
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