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

Last updated: May 10, 2023
Sponsor: Heinrich-Heine University, Duesseldorf
Overall Status: Completed

Phase

N/A

Condition

Congestive Heart Failure

Mitral Valve Regurgitation

Treatment

PASCAL vs. MitraClip

Clinical Study ID

NCT05865938
PASCAL vs. MitralClip
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 dueto a high

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 214
Treatment Group(s): 1
Primary Treatment: PASCAL vs. MitraClip
Phase:
Study Start date:
June 01, 2019
Estimated Completion Date:
August 31, 2022

Study 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)

Connect with a study center

  • Division of Cardiology, Pulmonary Disease and Vascular Medicine

    Düsseldorf, 40225
    Germany

    Site Not Available

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