Status:
RECRUITING
Prediction of Reverse Remodeling and Outcome in Patients With Severe Secondary Mitral Valve Regurgitation Undergoing Transcatheter Edge-to-edge Mitral Valve Repair
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
University Hospital, Basel, Switzerland
Cardiocentro Ticino
Conditions:
Severe Mitral Regurgitation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The investigators' hypothesis is that CMR tissue characterization and myocardial function analysis acquired by CMR feature tracking technique predict reverse remodeling in patients with severe seconda...
Detailed Description
Diametrically opposed results of the COAPT- and the MITRA-FR trial have demonstrated the need for additional evidence in the field of transcatheter mitral edge-to-edge repair. Reverse left ventricular...
Eligibility Criteria
Inclusion
- Patients with severe secondary MR characterized, according to the European guidelines and recommendations, by a regurgitant volume ≥30 mL/beat or an effective regurgitant orifice ≥20 mm².
- Symptomatic patients with New York Heart Association Class ≥II.
- Left ventricular ejection fraction between 15% and 50%.
- Optimal standard of care therapy for heart failure according to investigator.
- Not eligible for a mitral surgery intervention according to the Heart Team.
- Patients who have the ability to understand the requirements of the study and provide written consent/assent to participate and agree to abide by the study requirements.
Exclusion
- Participants younger than 18 years
- Pregnancy or breastfeeding
- Severe impaired renal function (GFR \< 15 ml/min)
- Patients with untreated severe concomitant valve disease (e.g. severe tricuspid valve regurgitation, aortic stenosis)
- The patient has a medical condition, serious concurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up
- The patient has contraindications to CMR, including: Implanted non-CMR conditional metallic implants, pacemaker, intracardiac defibrillator, neurostimulator, epicardial pacemaker leads, or any abandoned leads, ferromagnetic aneurysm clip, ferromagnetic halo device, cochlear implants, implanted infusion pumps or severe claustrophobia
- The patient is clinically unstable or has stage D congestive heart failure or inability to lay flat for 60 minutes
Key Trial Info
Start Date :
August 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04913727
Start Date
August 4 2021
End Date
December 31 2025
Last Update
October 18 2024
Active Locations (1)
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1
Department of Cardiology, University Hospital Bern, Inselspital, Bern
Bern, Switzerland, 3010