Clinical Trial

AHEAD: European Feasibility Study of the Cardiovalve Transfemoral Mitral Valve System

Study acronym: AHEAD
Active, Not Recruiting
View on ClinicalTrials.gov →
Summary
This study will evaluate the safety of the Cardiovalve Transfemoral Mitral Valve System with its associated procedure, and observe the device performance in reducing mitral regurgitation. Data collected in this clinical study will include 30-day safety and performance, and long-term clinical outcomes over a follow-up of 2 years.
Protocol Amendment History 13 amendments
This ClinicalTrials.gov record has been amended 13 times since 2017-11-07; most recent amendment 2026-03-16.
Status change: Recruiting → Active, Not Recruiting 2026-03-16
Status change: Not Yet Recruiting → Recruiting 2018-05-17
Trial Details
NCT Number NCT03339115
Lead Sponsor Cardiovalve Ltd.
Collaborators: Meditrial Europe Ltd., Meditrial SrL
Conditions Mitral Regurgitation, Mitral Valve Disease
Enrollment 30 participants
Start Date 2018-04-23
Primary Completion 2026-12-31 (estimated)
Study Completion 2030-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-17