CardiAQ TMVI System Study
Research type
Research Study
Full title
A Clinical Study of the CardiAQ™ Transcatheter Mitral Valve Implantation (TMVI) System (Transapical Delivery System) For the Treatment of Moderate to Severe Mitral Regurgitation
IRAS ID
172070
Contact name
Daniel Blackman
Contact email
Sponsor organisation
CardiAQ Valve Technologies, Inc.
Duration of Study in the UK
6 years, 0 months, 1 days
Research summary
The current recommended standard treatment for mitral valve replacement is open-heart surgery. However, the risks of open-heart surgery may be prohibitively high for patients who are older, have other significant heart disease, or have serious general health problems.
CardiAQ Valve Technologies, Inc. has developed the CardiAQ TMVI System to replace the mitral valve without the need for open-heart surgery. Instead, the CardiAQ Valve is implanted using a procedure called a transcatheter mitral valve implantation (TMVI). The purpose of this study is to evaluate the safety and performance of the CardiAQ TMVI System for patients with moderate to severe mitral valve regurgitation who are considered high or extreme risk for open-heart surgery replacement.The CardiAQ™ TMVI System is an investigational device that is not commercially available in Europe. Its use in this study is experimental. However, the CardiAQ™ TMVI System has been used in a limited numberof patients (6 patients) previously in situations where no other treatment option was available.
The CardiAQ™ TMVI System consists of a metal frame (stent), with a valve made from tissue from a cow’s heart (bovine) and a piece of polyester fabric that are sewn into the metal frame. The valve is designed to replace the mitral heart valve without open-heart surgery. The valve is implanted using a delivery catheter, which is a long tube with the valve attached at one end and a handle attached at the other end to control the placement of the valve. The long tube will be inserted through an incision in the chest between the ribs.
Approximately 60 patients will be enrolled into the study at up to 15 different hospitals across Europe. Patients that receive the CardiAQ Valve will take part in the study for approximately 5 years (61 months).
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
15/YH/0123
Date of REC Opinion
29 May 2015
REC opinion
Further Information Favourable Opinion