Evaluating a procedure for treating atrial functional mitral regurgitation
Assessment of Transcatheter Edge-to-Edge Repair in Atrial Functional Mitral Regurgitation
This study looks at how well a new heart procedure works for people with atrial functional mitral regurgitation to see if it helps improve their health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital of Cologne Academic / other |
| Locations | 22 sites (The Bronx, New York and 21 other locations) |
| Trial ID | NCT06911099 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the outcomes of patients with atrial functional mitral regurgitation who have undergone transcatheter edge-to-edge repair in a clinical setting. It is a multicenter, international, retrospective registry that collects data on patient outcomes to assess the effectiveness of this treatment approach. The study aims to provide insights into the routine clinical management of this condition and its implications for patient care.
Who should consider this trial
Good fit: Ideal candidates include adults with functional mitral regurgitation and a left ventricular ejection fraction of 50% or greater.
Not a fit: Patients under 18 years old or those with known regional wall movement disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment strategies for patients with atrial functional mitral regurgitation.
How similar studies have performed: Other studies have explored similar interventions, but the specific outcomes of this approach in the context of atrial functional mitral regurgitation are still being evaluated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * functional mitral regurgitation * left ventricular ejection fraction ≥50% Exclusion Criteria: * age under 18 years * known regional wall movement disorders
Where this trial is running
The Bronx, New York and 21 other locations
- Montefiore Medical Center — The Bronx, New York, United States (Recruiting)
- St. Michael's Hospital — Toronto, Canada (Recruiting)
- Bordeaux University Hospital — Bordeaux, France (Recruiting)
- University Hospital Center of Nantes — Nantes, France (Recruiting)
- LMU Klinikum — Munich, Bavaria, Germany (Recruiting)
- University Hospital Cologne — Cologne, North Rhine-Westphalia, Germany (Recruiting)
- HDZ Bad Oeynhausen — Bad Oeynhausen, Germany (Recruiting)
- Heart Center Bonn — Bonn, Germany (Recruiting)
- University Hospital of Düsseldorf — Düsseldorf, Germany (Recruiting)
- University Heart and Vascular Center Hamburg — Hamburg, Germany (Recruiting)
- University Hospital Schleswig-Holstein — Kiel, Germany (Recruiting)
- Heart Center Leipzig at University of Leipzig — Leipzig, Germany (Recruiting)
- Heart Center of the University Medical Center Mainz — Mainz, Germany (Recruiting)
- University Heart Center Ulm — Ulm, Germany (Recruiting)
- University of Brescia — Brescia, Italy (Recruiting)
- San Raffaele University Hospital — Milan, Italy (Recruiting)
- University of Pisa — Pisa, Italy (Recruiting)
- Hospital Clinic of Barcelona — Barcelona, Spain (Recruiting)
- Reina Sofia University Hospital — Córdoba, Spain (Recruiting)
- University Hospital of León — León, Spain (Recruiting)
- Asturias Central University Hospital — Oviedo, Spain (Recruiting)
- University Hospital Alvaro Cunqueiro — Vigo, Spain (Recruiting)
Study contacts
- Principal investigator: Christos Iliadis, MD — Heart Center, Department III of Internal Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Kerpener Straße 62, 50937, Cologne, Germany
- Study coordinator: Philipp von Stein, MD
- Email: philipp.von-stein@uk-koeln.de
- Phone: 646-321-8145
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.