Early transcatheter edge-to-edge mitral valve repair (TEER).
ProcedureTEER 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.
Recruiting
NCT Number: NCT06282042
Early Transcatheter Mitral Valve Repair After Myocardial Infarction
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–99 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Emek Medical Center, Afula, Israel
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About this study
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).
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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)
Treatment and study plan
mitraclip
DeviceMitraClip
Optimal medical treatment
OtherOptimal medical treatment
Primary outcomes
-
All-cause death or Cumulative Heart Failure hospitalizations
Time frame: 12 months
Composite of
- All-cause death
- Cumulative Heart Failure hospitalizations
Study contacts
Contact information is provided by the study sponsor or research team.
Isaac Pascual MD, PhD
CONTACT
Pablo Avanzas, MD, PhD
CONTACT
Sponsors and collaborators
Lead sponsor
Fundación para la Investigación Biosanitaria del Principado de Asturias
Other
Collaborators
- Meditrial Europe Ltd.
Registry information
Acronym: EMCAMI
Important dates
- Study start
- 2024
- Primary completion
- 2027
- Study completion
- 2028
- First posted
- Feb 28, 2024
- Registry last updated
- Oct 20, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.