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

Completed

• Conditions: Mitral Regurgitation; Degenerative Mitral Valve Regurgitation; Functional Mitral Regurgitation
• Interventions: Device: PASCAL vs. MitraClip

• Registration Number: NCT05865938
• Lead Sponsor: Heinrich-Heine University, Duesseldorf

Brief 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)

Study Timeline

• Study Start: 2019-06-01
• Primary Completion: 2022-08-31
• Study Completion: 2022-08-31
• Status Verified: 2023-05
• Study First Submitted: 2023-05-08
• Study First Submitted QC: 2023-05-10
• Last Update Submitted: 2023-05-10
• Study First Posted: 2023-05-19
• Last Update Posted: 2023-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 214

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PASCAL-Group	PASCAL vs. MitraClip	M-TEER using MitraClip
MitraClip-Group	PASCAL vs. MitraClip	M-TEER using PASCAL

Primary Outcome Measures

Name	Time	Method
Procedural success	one month after implantation	as defined by the Mitral Valve Academy Research Consortium (MVARC)
Composite endpoint of all-cause death and heart failure hospitalization	one year after implantation

Secondary Outcome Measures

Name	Time	Method
Grade of Mitral Regurgitation	one month and one year after implantation	measured by echocardiography
Functional status	one month and one year after implantation	according to New York Heart Association (NYHA) functional class

Trial Locations

Locations (1)

Division of Cardiology, Pulmonary Disease and Vascular Medicine; 🇩🇪 Düsseldorf, Germany