Tendyne Expanded Clinical Study
Research type
Research Study
Full title
Expanded Clinical Study of Tendyne Mitral Valve System
IRAS ID
215076
Contact name
Alison Duncan
Contact email
Sponsor organisation
Tendyne Holdings, Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
This clinical study will be conducted at up to twenty-five (25) sites in the United States, Europe, Australia and Latin America; approximately 110 patients will participate. The enrollment phase is anticipated to take 24 months, and subjects will be followed out to two years. The study is being organised and funded by a commercial company in the USA called Tendyne Holdings, Inc., Roseville (MN), USA, a subsidiary of Abbott Vascular, who are the manufacturers of the medical device and sponsor of this study.
The Tendyne Bioprosthetic Mitral Valve System is placed in an anatomical position above patient’s not properly functioning mitral valve. This means that patient’s mitral valve is not removed or otherwise disrupted. The study valve functions as a normal mitral valve would, closing when pressure increases in the left venticle as it begins to pump blood into the body and the valve opens again, when the left ventricle begins to relax and thus allows blood from the lungs to enter this chamber.
An important benefit in comparison with open heart surgical replacement of the mitral valve is that the study valve would be implanted through a small incision through the chest wall rather than a surgical procedure requiring the opening of the chest cavity and the use of a heart-lung machine. In such a situation, patient’s body is exposed to a physically taxing surgical procedure, associated risks and a longer recovery time.
The procedure will take place in an operating room of the hospital. Patient is placed under general anesthesia. Patient will be in a deep sleep and not feel any pain. The anesthetist will constantly monitor patient’s condition during the entire procedure. Prior to the procedure, patient will meet with the anesthetist, who will explain all the details and provide with appropriate informational leaflets.REC name
London - Queen Square Research Ethics Committee
REC reference
16/LO/1912
Date of REC Opinion
22 Nov 2016
REC opinion
Further Information Favourable Opinion