Recruiting NCT06911099
Assessment of Transcatheter Edge-to-Edge Repair in Atrial Functional Mitral Regurgitation (ATRIAL-MR)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Atrial Functional Mitral Regurgitation, Mitral Insufficiency. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada, France, Germany, Italy +1
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Assessment of Transcatheter Edge-to-Edge Repair in Atrial Functional Mitral Regurgitation
Overview
This investigator-initiated, multicenter, international, retrospective registry aims to investigate outcomes of patients with atrial functional mitral regurgitation, as treated in clinical routine.
Primary outcome measures
- Composite of all-cause mortality and heart-failure related rehospitalitzation [Time frame: 12 months]
Secondary outcome measures (7)
- Residual Mitral Regurgitation ≤1+ [Time frame: 12 months]
- All-cause mortality [Time frame: 12 months]
- Cardiovascular mortality [Time frame: 12 months]
- Heart failure related rehospitalization [Time frame: 12 months]
- Unplanned mitral valve intervention [Time frame: 12 months]
- New York Heart Association (NYHA) class III or IV [Time frame: 12 months]
- 6 Minute Walking Distance [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- functional mitral regurgitation
- left ventricular ejection fraction ≥50%
Exclusion criteria
- age under 18 years
- known regional wall movement disorders
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 10 centers
- LMU Klinikum — Munich
- University Hospital Cologne — Cologne
- HDZ Bad Oeynhausen — Bad Oeynhausen
- Heart Center Bonn — Bonn
- University Hospital of Düsseldorf — Düsseldorf
- University Heart and Vascular Center Hamburg — Hamburg
- University Hospital Schleswig-Holstein — Kiel
- Heart Center Leipzig at University of Leipzig — Leipzig
- … and 2 more centers
Spain · 5 centers
- Hospital Clinic of Barcelona — Barcelona
- Reina Sofia University Hospital — Córdoba
- University Hospital of León — León
- Asturias Central University Hospital — Oviedo
- University Hospital Alvaro Cunqueiro — Vigo
Italy · 3 centers
- University of Brescia — Brescia
- San Raffaele University Hospital — Milan
- University of Pisa — Pisa
France · 2 centers
- Bordeaux University Hospital — Bordeaux
- University Hospital Center of Nantes — Nantes
United States · 1 center
- Montefiore Medical Center — The Bronx
Canada · 1 center
- St. Michael's Hospital — Toronto
Identifiers
NCT: NCT06911099 · 24-1121