NCT05865938

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

PASCAL vs. MitralClip for Mitral Valve Transchatheter Edge-to-Edge Repair: A Prospective, Single-center, Open-label Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 214 (actual)
• Sponsor: Heinrich-Heine University, Duesseldorf · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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)

Conditions

• Mitral Regurgitation
• Functional Mitral Regurgitation
• Degenerative Mitral Valve Regurgitation

Interventions

Type	Name	Description
DEVICE	PASCAL vs. MitraClip	transcatheter mitral valve repair of the mitral valve (M-TEER) using the Edwards PASCAL Transcatheter Valve Repair System or 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 the 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.

Timeline

• Start date: 2019-06-01
• Primary completion: 2022-08-31
• Completion: 2022-08-31
• First posted: 2023-05-19
• Last updated: 2023-05-19

Locations

1 site across 1 country: Germany