MedTrace Logo

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

NCT03339115 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-03-17

No results posted yet for this study

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.

Conditions

  • Mitral Regurgitation
  • Mitral Valve Disease

Interventions

DEVICE

Cardiovalve Transfemoral Mitral Valve

The Cardiovalve Transfemoral Mitral Valve System is intended for use symptomatic patients with severe mitral regurgitation who are at elevated risk for surgical mitral valve repair or replacement and who are anatomically eligible for transfemoral mitral valve replacement with transseptal access to the left atrium.

Sponsors & Collaborators

  • Meditrial Europe Ltd.

    collaborator INDUSTRY

  • Meditrial SrL

    collaborator INDUSTRY

  • Cardiovalve Ltd.

    lead INDUSTRY

Principal Investigators

  • Georg Nickenig · Bonn Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-23
Primary Completion
2026-12-31
Completion
2030-12-31

Countries

  • Germany
  • Greece
  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03339115 on ClinicalTrials.gov