Clinical Trial

TVMR With the INNOVALVE System Trial - Early Feasibility Study

Name: TVMR With the INNOVALVE System Trial - Early Feasibility Study — clinical trial record (NCT04919980)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Study acronym: TWIST-EFS

Recruiting

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Record status

This record was last updated May 28, 2026 (before its estimated July 1, 2026 completion). Its status may not reflect the trial's current state.

Summary

Study to evaluate the safety and performance of the INNOVALVE system

Protocol Amendment History 1 change

notable Trial sites expanded: 17 -> 20 locations 2026-05-29

Trial Details

NCT Number	NCT04919980
Lead Sponsor	Edwards Lifesciences
Conditions	Mitral Valve Regurgitation (Degenerative or Functional)
Enrollment	65 participants
Start Date	2022-09-01
Primary Completion	2026-07-01 (estimated)
Study Completion	2031-07-01 (estimated)
Updated on ClinicalTrials.gov	2026-05-28