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Prediction of Reverse Remodeling and Outcome in Patients With Severe Secondary Mitral Valve Regurgitation Undergoing Transcatheter Edge-to-edge Mitral Valve Repair
RECRUITINGN/ASponsored by Insel Gruppe AG, University Hospital Bern
Actively Recruiting
PhaseN/A
SponsorInsel Gruppe AG, University Hospital Bern
Started2021-08-04
Est. completion2025-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT04913727
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 secondary mitral regurgitation (MR) undergoing transcatheter mitral edge-to-edge repair.
Eligibility
Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria: * 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 Criteria: * 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
Conditions2
Heart DiseaseSevere Mitral Regurgitation
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Actively Recruiting
PhaseN/A
SponsorInsel Gruppe AG, University Hospital Bern
Started2021-08-04
Est. completion2025-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT04913727