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

Mitral Regurgitation Clinical Trial

— PRIME-MR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05332782
• Other study ID #: PRIME-MR
• Status: Recruiting
• Start date: March 1, 2022
• Est. completion date: January 1, 2026

Study information

• Verified date: April 2022
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: Benedikt Koell, MD
• Phone: +4915222815230
• Email: b.koell[@]uke.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Valve Insufficiency

Locations

Country	Name	City	State
France	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
Germany	University Heart & Vascular Center Hamburg	Hamburg
Germany	Klinikum der Universität München	Munich
United States	Montefiore Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Countries where clinical trial is conducted

United States,  France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality	Incidence of death from any cause.	12 months
Primary	Cardiovascular mortality	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.	12 months
Primary	Rehospitalization for congestive heart failure	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.	12 months
Primary	Re-do mitral valve procedure	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.	12 months
Secondary	Residual mitral regurgitation	Mitral regurgitation severity (0, 1+, 2+, 3+, 4+) as assessed by transthoracic echocardiography at discharge.	up to 30 days
Secondary	Residual mitral regurgitation	Mitral regurgitation severity (0, 1+, 2+, 3+, 4+) as assessed by transthoracic echocardiography at 1-year follow-up.	12 months
Secondary	MVARC (Mitral Valve Academic Research Consortium) Technical success	All of the following must be present: Absence of procedural mortality; Successful access, delivery, and retrieval; Successful deployment and correct positioning of the first device; Freedom from emergency surgery or reintervention related to the device or access procedure	1 day (at exit from the catheterization laboratory)
Secondary	Functional success	If one of the following is present: Residual mitral regurgitation =2+; Effective regurgitant orifice area =15 mm2; Transmitral gradient <5 mmHg	1 day (at exit from the catheterization laboratory)