WithdrawnNot Applicable

TVMR With the Innovalve System Trial - TWIST-BE TWIST-PILOT-BE

Stopped: Stdy never submitted to any regulatory body or never initiated

0Started 2023-06-01

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Clinically significant, symptomatic mitral regurgitation * High risk for open-heart surgery * Meets anatomical criteria Exclusion Criteria: * Unsuitable anatomy * Patient is inoperable * EF \<30%

What they're measuring

Number of patients with implant or delivery related serious adverse events at 30 days

Timeframe: 30 days

Trial details

NCT IDNCT05263375

SponsorInnovalve Bio Medical Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-06-01

View on ClinicalTrials.gov More Mitral Valve Regurgitation (Degenerative or Functional) trials