Actively Recruiting
Assessment of Transcatheter Edge-to-Edge Repair in Atrial Functional Mitral Regurgitation
Led by University Hospital of Cologne · Updated on 2025-04-06
1000
Participants Needed
22
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating outcomes for patients with atrial functional mitral regurgitation who receive different treatments in routine clinical care. This international, multicenter, retrospective registry study aims to compare the results of patients treated with transcatheter edge-to-edge repair, transcatheter mitral valve replacement, or conservative guideline-directed medical therapy. The study focuses on real-world experiences and long-term patient outcomes. Participants are grouped based on the treatment they received: mitral valve transcatheter edge-to-edge repair, transcatheter mitral valve replacement, or conservative management with guideline-directed medical therapy. All devices used in these procedures are included. This observational study does not involve assigning treatments but collects data from past clinical care since January 2010. Participants' health outcomes are followed for 12 months, including death from any cause and rehospitalization for heart failure. Other measures include the severity of mitral regurgitation, cardiovascular death, unplanned mitral valve interventions, heart failure symptom severity (NYHA class III or IV), and physical ability measured by a 6-minute walking test. This long-term follow-up helps researchers understand the effectiveness and safety of the different management approaches.
CONDITIONS
Brief Title
Assessment of Transcatheter Edge-to-Edge Repair in Atrial Functional Mitral Regurgitation (ATRIAL-MR)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Functional mitral regurgitation
- Left ventricular ejection fraction 50% or higher
- Age 18 years or older
You will not qualify if you...
- Age under 18 years
- Known regional wall movement disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants who underwent mitral valve transcatheter edge-to-edge repair, transcatheter mitral valve replacement, or guideline directed medical therapy are observed to assess outcomes over time.
Regular visits over 12 months to assess health status and heart function
Trial Site Locations
Total: 22 locations
1
Montefiore Medical Center
The Bronx, New York, United States
Actively Recruiting
2
St. Michael's Hospital
Toronto, Canada
Actively Recruiting
3
Bordeaux University Hospital
Bordeaux, France
Actively Recruiting
4
University Hospital Center of Nantes
Nantes, France
Actively Recruiting
5
LMU Klinikum
Munich, Bavaria, Germany, 81377
Actively Recruiting
6
University Hospital Cologne
Cologne, North Rhine-Westphalia, Germany, 50937
Actively Recruiting
7
HDZ Bad Oeynhausen
Bad Oeynhausen, Germany
Actively Recruiting
8
Heart Center Bonn
Bonn, Germany
Actively Recruiting
9
University Hospital of Düsseldorf
Düsseldorf, Germany
Actively Recruiting
10
University Heart and Vascular Center Hamburg
Hamburg, Germany
Actively Recruiting
11
University Hospital Schleswig-Holstein
Kiel, Germany
Actively Recruiting
12
Heart Center Leipzig at University of Leipzig
Leipzig, Germany
Actively Recruiting
13
Heart Center of the University Medical Center Mainz
Mainz, Germany
Actively Recruiting
14
University Heart Center Ulm
Ulm, Germany
Actively Recruiting
15
University of Brescia
Brescia, Italy
Actively Recruiting
16
San Raffaele University Hospital
Milan, Italy
Actively Recruiting
17
University of Pisa
Pisa, Italy
Actively Recruiting
18
Hospital Clinic of Barcelona
Barcelona, Spain
Actively Recruiting
19
Reina Sofia University Hospital
Córdoba, Spain
Actively Recruiting
20
University Hospital of León
León, Spain
Actively Recruiting
21
Asturias Central University Hospital
Oviedo, Spain
Actively Recruiting
22
University Hospital Alvaro Cunqueiro
Vigo, Spain
Actively Recruiting
Research Team
P
Philipp von Stein, MD
C
Christos Iliadis, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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