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

NCT05865938 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 214

Last updated 2023-05-19

No results posted yet for this 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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Heinrich-Heine University, Duesseldorf

    lead OTHER

Principal Investigators

  • Malte Kelm, Prof. · Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf

  • Patrick Horn, MD · Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf

  • Jafer Haschemi, MD · Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2022-08-31
Completion
2022-08-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05865938 on ClinicalTrials.gov