Cardiac Surgery - PERIGON
MEDTRONIC PERICARDIAL SURGICAL AORTIC VALVE REPLACEMENT-PIVOTAL TRIAL
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.
Dr. Robert Hagberg and the Cardiac Surgery team will participate in this prospective, interventional, non-randomized, worldwide, multi-center trial. The purpose of this trial is to evaluate the safety and effectiveness of the Medtronic Model 400 aortic valve bioprosthesis in a patient undergoing surgical aortic valve replacement of a native aortic valve, or replacement of a failed prosthesis.
ELIGIBILITY CRITERIA:
- patients with moderate or greater aortic stenosis or regurgitation.
For more information please contact Amer Abdullah at 860-972-1250 or by email at Amer.abdullah@hhchealth.org