Clinical Trials Logo
  1. Home
  2. Mitral Regurgitation
  3. NCT03339115

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

Mitral Regurgitation Clinical Trial

Official title:
European Feasibility Study of High Surgical Risk Patients With Severe Mitral Regurgitation Treated With the Cardiovalve Transfemoral Mitral Valve System (AHEAD Study)

Clinical Trial 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.

Clinical Trial Description

The Cardiovalve offers a mitral replacement valve delivered through a transfemoral access and transseptal approach, and is intended to reduce mortality and adverse event rates in selected patients for whom surgical options are not feasible. Innovation: A truly trans femoral, trans venous delivery of the prosthetic mitral valve which minimizes procedural risk. The Cardiovalve Implant features a dual nitinol frame for robust radial strength with decoupling of the atrial flange and ventricular portion which contains 24 grasping legs designed for atraumatic anchoring of the device to the native mitral annulus. Valve leaflets are made of bovine pericardium. The Cardiovalve implant has a very low left ventricle (LV) protrusion footprint thus reducing the risk of LV outflow tract obstruction and/or interference with the LV. The Cardiovalve delivery system (DS) is designed for transfemoral delivery of the Implant with transseptal access to the left atrium. The catheter assembly is used to center the implant relative to the native mitral valve plane and align it with the left ventricual apex-to-base axis. After valve implantation, the delivery system is withdrawn. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03339115
Study type Interventional
Source Cardiovalve Ltd.
Contact Nitza Shoham, VP CA&A
Phone +972765388142
Email nitza@cardiovalve.com
Status Recruiting
Phase N/A
Start date April 23, 2018
Completion date December 31, 2029
View Details
See also
  Status Clinical Trial Phase
Completed NCT03278574 - Flexible Band vs Rigid Ring for Degenerative Mitral Valve Disease N/A
Suspended NCT04960280 - A Study to Evaluate a Computerized Stethoscope Called ©Voqx to Diagnose Heart Disease N/A
Recruiting NCT05021614 - Valveclip® Transcatheter Mitral Valve Repair Study N/A
Not yet recruiting NCT06167213 - ALLIANCE Mitral: Safety and Effectiveness of SAPIEN X4 Transcatheter Heart Valve - Mitral N/A
Not yet recruiting NCT06465745 - AltaValve Pivotal Trial N/A
Withdrawn NCT05040451 - Carillon Mitral Contour System for Treatment of Exercise Induced Functional Mitral Regurgitation
Withdrawn NCT03714412 - Feasibility Study of Patients With Severe MR Treated With the Cardiovalve TMVR System N/A
Recruiting NCT02592889 - (MitraClip in Non-Responders to Cardiac Resynchronization Therapy) Phase 4
Completed NCT02355418 - The Role of Myocardial Fibrosis in Degenerative Mitral Regurgitation
Completed NCT01841554 - Cardioband With Transfemoral Delivery System N/A
Not yet recruiting NCT01431222 - Abrogation of Mitral Regurgitation Using the MitraClip System in High-Risk Patients Unsuitable for Surgery Phase 4
Not yet recruiting NCT03870516 - Left Chamber Function in Mitral Regurgitation and Predicting Outcome After Replacement and Targeting for Early Surgery N/A
Active, not recruiting NCT03230747 - SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation N/A
Enrolling by invitation NCT04031274 - Transcatheter Treatment for Combined Aortic and Mitral Valve Disease. The Aortic+Mitral TRAnsCatheter (AMTRAC) Valve Registry
Completed NCT05836480 - Immediate Suboptimal Result of Mitral Valve Repair: Late Implications in a Matched Cohort Study
Completed NCT05836532 - Long Term Results of Surgical and Percutaneous Double Orefices Mitral Repair in Patient With p2 Prolapse Causing Degenerative Mitral Regurgitation
Completed NCT05850026 - Mitral Regurgitation in Hypertrophic Obstructive Cardiomyopathy: Fix it in a Simple, Effective and Durable Way!
Recruiting NCT03975998 - Dutch-AMR: Early Mitral Valve Repair Versus Watchful Waiting in Asymptomatic Patients With Severe Mitral Regurgitation
Completed NCT01162083 - Identifying an Ideal Cardiopulmonary Exercise Test Parameter N/A
Suspended NCT00787293 - Study of Safety and Efficacy of the Percutaneous Reduction of Mitral Valve Regurgitation in Heart Failure Patients Phase 2