PASCAL vs. MitralClip for Mitral Valve Transchatheter Edge-to-Edge Repair

Heinrich-Heine University, Duesseldorf

Status: Completed

Conditions: Degenerative Mitral Valve Regurgitation; Functional Mitral Regurgitation; Mitral Regurgitation

Treatments: Device: PASCAL vs. MitraClip

Study type: Observational

Funder types: Other

Identifiers

NCT05865938

PASCAL vs. MitralClip

Details and patient eligibility

About

Comparsion of the current two available TEER systems, the MitraClip with the PASCAL repair system in terms of their effectiveness and safety in patients with degenerative mitral regurgitation (DMR) and in patients with functional regurgitation (FMR), who were referred for an interventional therapy by the heart team due to a high surgical risk profile.

Full description

A prospective single-center, open-label study to evaluate the safety and effectiveness of transcatheter mitral valve repair of the mitral valve (M-TEER) using the Edwards PASCAL Transcatheter Valve Repair System compared to using the Abbott MitraClip in patients with severe and symptomatic degenerative or functional mitral regurgitation (FMR). The type of device system used was not randomized but was determined by the operational structuring of our mitral valve program such that patients were scheduled for the next available implantation date with weekly alternating time slots for MitraClip device and PASCAL device. Treating physicians had no influence on scheduling or system selection.

Follow-up examinations will be performed one month and one year after the procedure with assessment of echocardiographic and functional status based on the New York Heart Association (NYHA) grade. Patient characteristics, baseline data, and data related to the procedure were assessed using a registry, medical records and the procedure protocols.

This study is a subproject of the MitraClip® Registry (NCT02033811)

Enrollment: 214 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years
• Severe Mitral Regurgitation (3+ to 4+)
• Symptom status: NYHA functional class ≥ II
• Patients with FMR or DMR, who were referred for M-TEER by the heart team decision due to a high

Exclusion criteria

• Life expectancy < 1 year
• Anatomy of the mitral valve that may not be suitable for the MitraClip or PASCAL device
• Contraindication for transoesophageal echocardiography
• Active endocarditis
• Pregnant or planning pregnancy within next 12 months

Trial design

214 participants in 2 patient groups

PASCAL-Group

Description:

M-TEER using MitraClip

Treatment:

Device: PASCAL vs. MitraClip

MitraClip-Group

Description:

M-TEER using PASCAL

Treatment:

Device: PASCAL vs. MitraClip