Predicting heart recovery in patients with severe mitral valve issues undergoing a specific repair procedure
Prediction of Reverse Remodeling and Outcome in Patients With Severe Secondary Mitral Valve Regurgitation Undergoing Transcatheter Edge-to-edge Mitral Valve Repair
This study is testing if special heart imaging can help doctors figure out which patients with severe mitral valve problems will recover well after a specific repair procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 1 site (Bern) |
| Trial ID | NCT04913727 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate how cardiac magnetic resonance (CMR) imaging can predict heart recovery in patients with severe secondary mitral regurgitation who are undergoing transcatheter edge-to-edge mitral valve repair. By analyzing myocardial function and tissue characteristics through advanced CMR techniques, the researchers hope to identify which patients are likely to benefit from the procedure. The study addresses the challenges of patient selection for this treatment by providing evidence-based predictions of treatment response and outcomes. It builds on previous findings regarding myocardial fibrosis and its impact on heart function.
Who should consider this trial
Good fit: Ideal candidates include symptomatic patients aged 18 and older with severe secondary mitral regurgitation and left ventricular ejection fractions between 15% and 50%.
Not a fit: Patients with untreated severe concomitant valve disease or those with severely impaired renal function may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved patient selection for mitral valve repair, enhancing treatment outcomes for those with severe mitral regurgitation.
How similar studies have performed: Previous studies have shown promising results using similar CMR techniques for predicting outcomes in heart failure patients, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bern
- Department of Cardiology, University Hospital Bern, Inselspital, Bern — Bern, Switzerland (Recruiting)
Study contacts
- Principal investigator: Christoph MD Gräni, PHD — Department of Cardiology, University Hospital Bern, Inselspital, Bern
- Study coordinator: Christoph MD Gräni, PHD
- Email: christoph.graeni@insel.ch
- Phone: +41 31 632 4508
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.