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To evaluate the safety and effectiveness of the Model 400 aortic valve bioprosthesis.
Condition or disease
Device: Model 400 aortic valve bioprosthesis
This is a prospective, interventional, non-randomized, worldwide, multi-center trial, with each site following a common protocol. A maximum of 1300 subjects will be implanted at a maximum of 40 sites in the US, Europe and Canada. The trial will include male and female patients of legal age to provide informed consent in the country where they enroll in the trial, requiring replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic valve. Patients will be followed and assessed after implant for up to 5 years.
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
Actual Study Start Date :
May 12, 2014
Actual Primary Completion Date :
July 27, 2018
Estimated Study Completion Date :
July 27, 2022
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Evaluate the safety of the Model 400 valve with regard to valve-related adverse events and death. [ Time Frame: Patients are followed through 5yrs ]
Safety of the valve will be evaluated by the time-related incidence of valve-related adverse events and death. The following valve-related adverse events will be evaluated in this study: Thromboembolism, Thrombosis, Hemorrhage, Paravalvular leak (PVL), Endocarditis, Hemolysis, Structural valve deterioration, Non-structural dysfunction, Reintervention, Explant, and Death.
Secondary Outcome Measures :
Confirm the effectiveness of the Model 400 valve, with regard to NYHA Functional Classification and hemodynamic performance. [ Time Frame: Patients are followed through 5yrs ]
The effectiveness endpoints are:
New York Heart Association Functional Classification (at discharge (or 30 days), 3-6 months, 1 year and annually thereafter through 5 years) as compared to Baseline.
Clinically acceptable Hemodynamic Performance (at discharge (or 30 days), 3-6 months, 1 year and annually thereafter through 5 years) confirmed by core lab evaluation of echocardiography.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patient has moderate or greater aortic stenosis or regurgitation, and there is clinical indication for replacement of their native or prosthetic aortic valve with a bioprosthesis, with or without concomitant procedures, which are limited to any of the following:
i. LAA ligation ii. CABG iii. PFO closure iv. Ascending aortic aneurysm or dissection repair not requiring circulatory arrest v. Resection of a sub-aortic membrane not requiring myectomy
Patient is geographically stable and willing to return to the implanting site for all follow-up visits
Patient is of legal age to provide informed consent in the country where they enroll in the trial
Patient has been adequately informed of risks and requirements of the trial and is willing and able to provide informed consent for participation in the clinical trial
Patient has a pre-existing prosthetic valve or annuloplasty device in another position or requires replacement or repair of the mitral, pulmonary or tricuspid valve
Patient has had previous implant and then explant of the Model 400 aortic valve bioprosthesis
Patient presents with active endocarditis, active myocarditis or other systemic infection
Patient has an anatomical abnormality which would increase surgical risk of morbidity or mortality, including:
Ascending aortic aneurysm or dissection repair requiring circulatory arrest