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

NCT ID: NCT07108907

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-10
• Study Completion Date: 2035-01-01

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.

Detailed Description

Mitral regurgitation (MR) affects more than 10% of individuals over the age of 75, and with an aging population, its prevalence is expected to continue rising in the coming years. Treatment options include surgical repair, surgical replacement, medical therapy, cardiac resynchronization therapy (CRT), or transcatheter valve repair. For percutaneous mitral valve repair, the transcatheter edge-to-edge repair (M-TEER) technique is the preferred approach. This technique involves the use of the MitraClip (Abbott) and PASCAL (Edwards) devices, which are derived from the surgical Alfieri technique.

Since 2009, the M-TEER procedure has been performed in patients who, based on assessment by the heart team and mitral valve team, are deemed unsuitable for surgery but are eligible for this percutaneous treatment.

Using data from all patients undergoing M-TEER at Amsterdam UMC, the investigators aim to conduct research focused on improving patient selection and alleviating symptoms associated with mitral valve disease.

Conditions

Mitral Regurgitation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Mitraclip

all patients receiving a mitraclip

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Unable to complete the questionnaires

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abby Geerlings

OTHER

Sponsor Role: lead

Responsible Party

Abby Geerlings

PhD Candidate, MD

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Amsterdam UMC

Amsterdam, North Holland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Abby E Geerlings, MD

Role: CONTACT

a.e.geerlings@amsterdamumc.nl

+31205669467

Facility Contacts

Abby E Geerlings, MD

Role: primary

a.e.geerlings@amsterdamumc.nl

+31205669467

Other Identifiers

2025.0301

Identifier Type: -

Identifier Source: org_study_id