TVMR With the Innovalve System Trial - Pilot in Georgia

Last updated: April 18, 2025
Sponsor: Edwards Lifesciences
Overall Status: Completed

Phase

N/A

Condition

Mitral Valve Regurgitation

Treatment

Innovalve MR system

Clinical Study ID

NCT05682066
INVL21-01-GE
  • 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<25%

Study Design

Total Participants: 11
Treatment Group(s): 1
Primary Treatment: Innovalve MR system
Phase:
Study Start date:
December 01, 2021
Estimated Completion Date:
January 01, 2025

Study Description

The study is a multi-center, First-In-Human, prospective, single pilot study to evaluate the safety and performance of the Innovalve mitral valve replacement system

Connect with a study center

  • Tbilisi Heart and Vascular Clinic

    Tbilisi,
    Georgia

    Site Not Available

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