Evaluating a procedure for treating atrial functional mitral regurgitation
Official title: Assessment of Transcatheter Edge-to-Edge Repair in Atrial Functional Mitral Regurgitation
Run by University Hospital of Cologne · NCT06911099 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | University Hospital of Cologne Academic / other |
| Locations | 22 sites (The Bronx, New York and 21 other locations) |
| Status | Recruiting |
| Started | January 1, 2010 |
| Main results expected | December 31, 2030 |
| Study ends | December 31, 2035 |
| Registry record updated | April 6, 2025 |
| Trial ID | NCT06911099 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults with functional mitral regurgitation and a left ventricular ejection fraction of 50% or greater.
✕Probably not a fit
Patients under 18 years old or those with known regional wall movement disorders may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
Why it matters
Potential benefit: If successful, this study could improve treatment strategies for patients with atrial functional mitral regurgitation.
How similar studies have gone: 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.
Who can join: the full rules
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 it's running
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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
Show 16 more locations
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Valsartan for Atrial Functional Mitral Regurgitation (AFMR) — Pilot
Atrial functional mitral regurgitation is studied to see if valsartan can slow its progression in adults with good heart pump function.
-
Transcatheter Edge-to-Edge Repair for Atrial Functional Mitral Regurgitation
This trial tests whether a transcatheter edge-to-edge repair device helps people with atrial functional mitral regurgitation who still have symptoms despite standard therapy.
-
Transcatheter Mitral and Tricuspid Interventions and Cardiac MRI Registry
This study will collect imaging and clinical data from adults undergoing transcatheter mitral or tricuspid procedures to see how their heart structure and function change over time using MRI and advanced ultrasound.
-
Predicting afterload mismatch after transcatheter mitral edge-to-edge repair
It will test a model to predict which adults having transcatheter mitral valve edge-to-edge repair will develop afterload mismatch after the procedure.
-
Catheter ablation for people with persistent atrial fibrillation and severe atrial functional mitral regurgitation
This will test whether adding catheter ablation to usual medicines helps adults with persistent atrial fibrillation and moderate-to-severe or severe atrial functional mitral regurgitation reduce valve leakage and improve symptoms and outcomes.
-
Assessing risks and outcomes in patients with mitral regurgitation
This study looks at patients with moderate to severe mitral regurgitation to see what factors might affect their health outcomes and help doctors make better treatment decisions.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.