Learn more about the AHEAD study
and see if it is right for you
About the study
The objective of this study is to evaluate the safety and the performance of the Cardiovalve System in the treatment of mitral valve regurgitation through the replacement of the damaged native valve using the prosthesis named the Cardiovalve Transfemoral Mitral Valve System. The new investigational device is comprised of the Cardiovalve Implant and the Cardiovalve Delivery System.
The Cardiovalve System is an investigational device, not currently for sale in Europe and the USA. It is not CE marked, and not FDA approved, but was successfully tested in animals and in the laboratory to confirm its safety and performance.
Data collected in this clinical study will include 30-day safety and performance of the device and delivery system, and long-term clinical outcomes over a follow-up of 3 years.
Who can join?
The AHEAD trial is recruiting patients with severe mitral valve regurgitation (mitral regurgitation), who cannot undergo an open heart surgery (which uses an incision of the sternum and a machine dedicated to maintaining the blood flow in your heart) for the replacement of the mitral valve, because that surgery would pose a high risk of serious complications and requires certain anatomical criteria.
An initial list of requirements to participate in the AHEAD trial appears below. For a complete list of inclusion criteria, click here. You can contact our trial centers directly for additional information.