Efficacy of MitraCLip Vs. PASCAL for the TrEAtment of MitraL REgurgiTation in an All-comer Population

Last updated: October 8, 2024
Sponsor: LMU Klinikum
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Failure

Congestive Heart Failure

Heart Valve Disease

Treatment

Transcatheter mitral valve edge-to-edge repair (M-TEER)

Clinical Study ID

NCT06634121
LEAFLET I
  • Ages > 18
  • All Genders

Study Summary

To investigate potential differences in procedural outcomes of both commercially available transcatheter edge-to-edge mitral valve repair devices in a non-selected clinical setting.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age equal or above 18 years

  • Written consent

  • Heart Team recommends M-TEER

Exclusion

Exclusion Criteria:

  • Mitral Stenosis (MV mean PG > 5 mmHg)

  • Cardiogenic shock or hemodynamic instability at the time of intervention

  • Active endocarditis

  • Participant in another interventional cardiology study

Study Design

Total Participants: 180
Treatment Group(s): 1
Primary Treatment: Transcatheter mitral valve edge-to-edge repair (M-TEER)
Phase:
Study Start date:
April 01, 2024
Estimated Completion Date:
April 01, 2028

Study Description

In the context of M-TEER, two different systems (MitraClip vs. PASCAL) are CE certified and clinically available. In the case of non-complex anatomy, both systems are comparable in terms of effectiveness. Whether this holds true in cases of complex or highly complex anatomy in an "Allcomer patient population" is currently unclear.

Connect with a study center

  • LMU Klinikum

    Munich, Bavaria 81377
    Germany

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.