RECRUITINGINTERVENTIONAL
Early Transcatheter Mitral Valve Repair After Myocardial Infarction
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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:
Who Should NOT Join This Trial:
- Primary MR (e.g. papillary muscle rupture)
- EF ≤ 25%
- Accepted for CABG
- Presence of cardiogenic shock (AMR type 1)
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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)
Treatments Being Tested
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
Locations (20)
Emek Medical Center
Afula, Afula, Israel
Shaare Zedek Medical Center
Jerusalem, Jerusalen, Israel
Rabin Medical Center
Petah Tikva, Petah Tikva, Israel
Sheba Medical Center
Ramat Gan, Ramat Gan, Israel
Civil Hospital of Brescia
Brescia, Brescia, Italy
Ospedale Policlinico San Martino
Genova, Genova, Italy
San Raffaele Hospital
Milan, Milano, Italy
Centro Cardiológico Monzino
Milan, Milan, Italy
Policlínico San Donato
San Donato Milanese, San Donato Milanese, Italy
Amsterdam University Medical Center
Amsterdam, Amsterdam, Netherlands
Amphia Hospital
Breda, Breda, Netherlands
Catharina Ziekenhuis Hospital
Eindhoven, Eindhoven, Netherlands
Leiden University Medical Center
Leiden, Leiden, Netherlands
Maastricht University Medical Center
Maastricht, Maastricht, Netherlands
St. Antonius Hospital
Nieuwegein, Nieuwegein, Netherlands
Erasmus University Medical Center
Rotterdam, Rotterdam, Netherlands
Isala Hospital
Zwolle, Zwolle, Netherlands
Hospital General Universitario Dr. Balmis
Alicante, Alicante, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
Hospital Universitario Vall d'Hebrón
Barcelona, Barcelona, Spain