TVMR With the Innovalve System Trial - Pilot Study in Italy

Last updated: June 23, 2025
Sponsor: Edwards Lifesciences
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Mitral Valve Regurgitation

Treatment

Innovalve TMVR system

Clinical Study ID

NCT05010746
INVL20-01-IT
  • Ages > 18
  • All Genders

Study Summary

Study to evaluate the safety and performance of the Innovalve mitral valve replacement system

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Clinically significant, symptomatic mitral regurgitation

  • High risk for open-heart surgery

  • Meets anatomical criteria

Exclusion

Exclusion Criteria:

  • Unsuitable anatomy

  • Patient is inoperable

  • EF <30%

Study Design

Total Participants: 4
Treatment Group(s): 1
Primary Treatment: Innovalve TMVR system
Phase:
Study Start date:
January 24, 2023
Estimated Completion Date:
October 04, 2029

Connect with a study center

  • Humanitas

    Milan,
    Italy

    Site Not Available

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.