PERIGON Pivotal Trial
Research type
Research Study
Full title
Medtronic PERIGON trail; A multi-center, non-randomized trial to determine the safety and effectiveness of the Model 400 aortic valve bioprosthesis in patients with aortic valve disease.
IRAS ID
134481
Contact name
Kamran Baig
Contact email
Duration of Study in the UK
6 years, 0 months, 1 days
Research summary
Aortic stenosis (a disease of the heart valves in which the opening of the aortic valve is narrowed) and chronic aortic regurgitation (a disease of the heart in which blood leaks back to the heart)are the most prevalent valve disorders among elderly patients. Open-heart surgery to replace the diseased aortic valve is the standard treatment. Surgical Aortic Valve Replacement with tissue bioprosthesis has become the preferred valve treatment for patients over 65 years of age.
Medtronic has developed the model 400 aortic valve bioprosthesis, a stented bovine pericardial tissue valve. This valve has been designed to incorporate the proven attributes of the leading bovine pericardial heart valves along with the use of the anti-calcification agent alpha amino oleic acid (AOA™) which has been shown to mitigate leaflet calcification.In order to evaluate the safety and effectiveness of the Model 400 aortic valve bioprosthesis, Medtronic will be conducting a worldwide, multi-center pre-market trial with all sites following a common protocol. The target population includes all subjects who are candidates for a aortic tissue prosthetic valve. The PERIGON Pivotal Trial is designed to enroll a maximum of 650 patients at a maximum of 40 sites. The patients will be followed-up for five years.
REC name
London - Dulwich Research Ethics Committee
REC reference
14/LO/0353
Date of REC Opinion
28 Apr 2014
REC opinion
Further Information Favourable Opinion