Clinical Trial

TVMR With the Innovalve System Trial - Pilot Study in Italy

Study acronym: TWIST-PILOT-IT
Active, Not Recruiting
View on ClinicalTrials.gov →
Summary
Study to evaluate the safety and performance of the Innovalve mitral valve replacement system
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2021-08-11; most recent amendment 2025-06-23.
Status change: Recruiting → Active, Not Recruiting 2025-04-18
Status change: Not Yet Recruiting → Recruiting 2023-01-22
Trial Details
NCT Number NCT05010746
Lead Sponsor Edwards Lifesciences
Conditions Mitral Valve Regurgitation (Degenerative or Functional)
Enrollment 4 participants
Start Date 2023-01-24
Primary Completion 2024-05-04 (estimated)
Study Completion 2029-10-04 (estimated)
Updated on ClinicalTrials.gov 2025-06-26