TVMR With the Innovalve System Trial - Pilot Study in Italy

Last updated: March 5, 2024
Sponsor: Innovalve Bio Medical Ltd.
Overall Status: Active - 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: 10
Treatment Group(s): 1
Primary Treatment: Innovalve TMVR system
Phase:
Study Start date:
January 01, 2023
Estimated Completion Date:
January 01, 2028

Connect with a study center

  • Humanitas

    Milan,
    Italy

    Active - Recruiting

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