Clinical Trial

HighFLO Study - HighLife Trans-septal Mitral Valve Replacement (TSMVR) Feasibility Study of the Open Cell CLARITY Valve

Study acronym: HighFLO
Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated October 3, 2024 (before its estimated December 1, 2025 completion). Its status may not reflect the trial's current state.
Summary
Feasibility, safety and performance of the HighLife CLARITY TSMV and its delivery system
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2021-05-11; most recent amendment 2024-10-01.
Status change: Not Yet Recruiting → Recruiting 2021-08-25
Trial Details
NCT Number NCT04888247
Lead Sponsor HighLife SAS
Conditions Mitral Regurgitation
Enrollment 30 participants
Start Date 2021-07-01
Primary Completion 2025-12-01 (estimated)
Study Completion 2031-02-01 (estimated)
Updated on ClinicalTrials.gov 2024-10-03