Outcome Registry and Assessment of New Edge-to-Edge Repair

NCT07108907 | Recruiting

• 1 other identifier: 2025.0301
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn about the long-term effects of Edge-tot-edge repair of all the patients of AmsterdamUMC, to treat their Mitral regurgitation (MR). The main question it aims to answer is: The patient selection process could be optimized. Participants are already receiving edge-to-edge repair as part of their standard medical care and will additionally complete quality-of-life survey questions.

Conditions

Mitral Regurgitation

Keywords

Mitraclip

Outcome Measures

Primary Outcomes (2)

• Change in quality of life measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)

  Change in health-related quality of life as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline to 6 months. The KCCQ is a validated, disease-specific instrument measuring physical function, symptoms, social limitations, and quality of life in patients with heart failure. Scores range from 0 to 100, with higher scores indicating better health status. Unit of Measure: KCCQ score (0-100)

  Baseline and 6 months

• Change in quality of life measured by the 36-Item Short Form Survey (SF-36)

  Change in health-related quality of life as assessed by the 36-Item Short Form Survey (SF-36) from baseline to 6 months. The SF-36 is a validated, generic instrument assessing physical and mental health across 8 domains. Scores are standardized to a 0-100 scale, with higher scores indicating better perceived health. Unit of Measure: SF-36 score (0-100)

  Baseline and 6 months

Study Arms (1)

Mitraclip

all patients receiving a mitraclip

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

all patients recieving a M-TEER procedure

You may qualify if:

• Age ≥ 18 years
• Accepted for M-TEER (Minimally Invasive Transcatheter Edge-to-Edge Repair) procedure

You may not qualify if:

• \- Unable to complete the questionnaires

Sponsors & Collaborators

• Abby Geerlings: lead

Study Sites (1)

Amsterdam UMC

Amsterdam, North Holland, 1105 AZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Abby E Geerlings, MD

CONTACT

+31205669467; a.e.geerlings@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD Candidate, MD

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 7, 2025
• Study Start: July 10, 2025
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2035
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)