Assessment of Transcatheter Edge-to-Edge Repair in Atrial Functional Mitral Regurgitation (ATRIAL-MR)

Recruiting

• Conditions: Atrial Functional Mitral Regurgitation; Mitral Insufficiency

• Registration Number: NCT06911099
• Lead Sponsor: University Hospital of Cologne

Brief Summary

This investigator-initiated, multicenter, international, retrospective registry aims to investigate outcomes of patients with atrial functional mitral regurgitation, as treated in clinical routine.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-01
• Study First Submitted: 2025-03-28
• Study First Submitted QC: 2025-03-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Study First Posted: 2025-04-04
• Last Update Posted: 2025-04-06
• Primary Completion: 2030-12-31
• Study Completion: 2035-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• functional mitral regurgitation
• left ventricular ejection fraction ≥50%

Exclusion Criteria

• age under 18 years
• known regional wall movement disorders

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite of all-cause mortality and heart-failure related rehospitalitzation	12 months

Secondary Outcome Measures

Name	Time	Method
New York Heart Association (NYHA) class III or IV	12 months	Assessment of New York Heart Association (NYHA) classification stage (in- or outpatient), with the minimum of I (no symptoms) and the maximum of IV (dyspnea at rest), with higher values indicating worse functional capacity.
6 Minute Walking Distance	12 months
Residual Mitral Regurgitation ≤1+	12 months	Rate of patients achieving residual mitral regurgitation ≤1+ measured by transthoracic echocardiography. Assessment of mitral regurgitation severity according to current guidelines (ESC/EACTS and ACC/AHA) for valvular heart disease.
All-cause mortality	12 months
Cardiovascular mortality	12 months
Heart failure related rehospitalization	12 months	Incidence of new-onset or worsening signs and symptoms of heart failure that required urgent therapy and resulted in hospitalization.
Unplanned mitral valve intervention	12 months	Incidence of unplanned surgical or transcatheter re-intervention, heart transplantation or left ventricular assist device implantation.

Trial Locations

Locations (22)

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States

University Hospital Center of Nantes; 🇫🇷 Nantes, France

LMU Klinikum; 🇩🇪 Munich, Bavaria, Germany

University Hospital Cologne; 🇩🇪 Cologne, NRW, Germany

HDZ Bad Oeynhausen; 🇩🇪 Bad Oeynhausen, Germany

Heart Center Bonn; 🇩🇪 Bonn, Germany

University Hospital of Düsseldorf; 🇩🇪 Düsseldorf, Germany

St. Michael's Hospital; 🇨🇦 Toronto, Canada

Bordeaux University Hospital; 🇫🇷 Bordeaux, France

University of Brescia; 🇮🇹 Brescia, Italy

San Raffaele University Hospital; 🇮🇹 Milan, Italy

University of Pisa; 🇮🇹 Pisa, Italy

Hospital Clinic of Barcelona; 🇪🇸 Barcelona, Spain

Reina Sofia University Hospital; 🇪🇸 Cordoba, Spain

University Hospital of León; 🇪🇸 Leon, Spain

Asturias Central University Hospital; 🇪🇸 Oviedo, Spain

University Hospital Alvaro Cunqueiro; 🇪🇸 Vigo, Spain

University Heart and Vascular Center Hamburg; 🇩🇪 Hamburg, Germany

University Hospital Schleswig-Holstein; 🇩🇪 Kiel, Germany

Heart Center Leipzig at University of Leipzig; 🇩🇪 Leipzig, Germany

Heart Center of the University Medical Center Mainz; 🇩🇪 Mainz, Germany

University Heart Center Ulm; 🇩🇪 Ulm, Germany