Clinical Trial

Cardiovalve Transfemoral System - FIM Study

Enrolling by Invitation
View on ClinicalTrials.gov →
Summary
The Cardiovalve system is a replacement valve delivered through a transfemoral access and transseptal approach and is intended for symptomatic patients with Mitral regurgitation for whom surgical options are not feasible.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2019-05-19; most recent amendment 2025-12-31.
Status change: Recruiting → Enrolling by Invitation 2025-12-31
Trial Details
NCT Number NCT03958773
Lead Sponsor Cardiovalve Ltd.
Collaborators: Meditrial Europe Ltd.
Conditions Mitral Regurgitation
Enrollment 10 participants
Start Date 2017-10-12
Primary Completion 2026-10-30 (estimated)
Study Completion 2026-10-30 (estimated)
Updated on ClinicalTrials.gov 2026-01-05