Outcomes of Patients tReated wIth Mitral Transcatheter Edge-to-edge Repair for Primary Mitral Regurgitation Registry

Recruiting

• Conditions: Mitral Regurgitation

• Registration Number: NCT05332782
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief Summary

This multinational, non-interventional, investigator-initiated, retrospective study aims to investigate outcomes of patients, who underwent mitral valve transcatheter edge-to-edge repair (M-TEER) for primary mitral regurgitation (PMR).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-01
• Study First Submitted: 2022-03-01
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-11
• Last Update Submitted: 2022-04-11
• Study First Posted: 2022-04-18
• Last Update Posted: 2022-04-18
• Primary Completion: 2025-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• clinically significant primary mitral regurgitation
• patient underwent M-TEER
• echocardiography data at baseline, procedure and follow-up
• follow-up of at least 12 months

Exclusion Criteria

• age under 18 years

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause mortality	12 months	Incidence of death from any cause.
Cardiovascular mortality	12 months	Incidence of cardiovascular death, defined as death attributable to myocardial ischemia and infarction, heart failure, cardiac arrest because of other or unknown cause, or cerebrovascular accident.
Rehospitalization for congestive heart failure	12 months	Incidence of new-onset or worsening signs and symptoms of heart failure that required urgent therapy and resulted in hospitalization, e.g. as assessed by patient interviews or medical records.
Re-do mitral valve procedure	12 months	Incidence of unplanned surgical (mitral valve repair or replacement) or transcatheter re-intervention (re-do transcatheter edge-to-edge repair), e.g. as assessed by patient interviews or medical records.

Secondary Outcome Measures

Name	Time	Method
Residual mitral regurgitation	12 months	Mitral regurgitation severity (0, 1+, 2+, 3+, 4+) as assessed by transthoracic echocardiography at 1-year follow-up.
MVARC (Mitral Valve Academic Research Consortium) Technical success	1 day (at exit from the catheterization laboratory)	All of the following must be present: 1. Absence of procedural mortality; 2. Successful access, delivery, and retrieval; 3. Successful deployment and correct positioning of the first device; 4. Freedom from emergency surgery or reintervention related to the device or access procedure
Functional success	1 day (at exit from the catheterization laboratory)	If one of the following is present: 1. Residual mitral regurgitation ≤2+; 2. Effective regurgitant orifice area ≤15 mm2; 3. Transmitral gradient \<5 mmHg

Trial Locations

Locations (6)

Centre Hospitalier de Bordeaux; 🇫🇷 Bordeaux, France

Université Lille, Inserm, Centre Hospitalier Universitaire de Lille; 🇫🇷 Lille, France

University Hospital of Rennes, Centre Hospitalier de Rennes; 🇫🇷 Rennes, France

Klinikum der Universität München; 🇩🇪 Munich, Germany

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

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