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

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).

Study Overview

• Status: Recruiting
• Conditions: Mitral Regurgitation

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Benedikt Koell, MD; Phone Number: +4915222815230; Email: b.koell@uke.de
• Study Contact Backup: Name: Sebastian Ludwig, MD; Phone Number: +491522816168; Email: se.ludwig@uke.de

Study Locations

• France
  • Bordeaux, France
    • Recruiting
    • Centre Hospitalier de Bordeaux
    • Contact: Thomas Modine, MD, PhD
  • Lille, France
    • Recruiting
    • Université Lille, Inserm, Centre Hospitalier Universitaire de Lille
    • Contact: Augustin Coisne, MD
  • Rennes, France
    • Recruiting
    • University Hospital of Rennes, Centre Hospitalier de Rennes
    • Contact: Erwan Donal, MD
• Germany
  • Hamburg, Germany, 20246
    • Recruiting
    • University Heart & Vascular Center Hamburg
    • Contact: Benedikt Koell, MD; Phone Number: +4915222815230; Email: b.koell@uke.de
    • Principal Investigator: Daniel Kalbacher, MD
  • Munich, Germany
    • Recruiting
    • Klinikum der Universität München
    • Contact: Jörg Hausleiter, MD
• United States
  • New York
    • New York, New York, United States, 10467
      • Recruiting
      • Montefiore Medical Center
      • Contact: Azeem Latib, MD
      • Contact: Andrea Scotti, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients undergoing transcatheter edge-to-edge repair for primary mitral regurgitation

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
M-TEER; Patients with primary mitral regurgitation undergoing mitral valve transcatheter edge-to-edge repair.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	Incidence of death from any cause.	12 months
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Residual mitral regurgitation	Mitral regurgitation severity (0, 1+, 2+, 3+, 4+) as assessed by transthoracic echocardiography at discharge.	up to 30 days
Residual mitral regurgitation	Mitral regurgitation severity (0, 1+, 2+, 3+, 4+) as assessed by transthoracic echocardiography at 1-year follow-up.	12 months
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)
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)

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Daniel Kalbacher, MD, University Heart & Vascular Center Hamburg

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Anticipated): January 1, 2025
• Study Completion (Anticipated): January 1, 2026

Study Registration Dates

• First Submitted: March 1, 2022
• First Submitted That Met QC Criteria: April 11, 2022
• First Posted (Actual): April 18, 2022

Study Record Updates

• Last Update Posted (Actual): April 18, 2022
• Last Update Submitted That Met QC Criteria: April 11, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: PRIME-MR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No