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
Overview
- Phase
- Not Applicable
- Intervention
- Model 400 aortic valve bioprosthesis
- Conditions
- Aortic Stenosis
- Sponsor
- Medtronic Cardiac Surgery
- Enrollment
- 1312
- Locations
- 76
- Primary Endpoint
- Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant
- Status
- Active, not recruiting
- Last Updated
- 3 days ago
Overview
Brief Summary
To evaluate the safety and effectiveness of the Model 400 aortic valve bioprosthesis.
Detailed Description
This is a prospective, interventional, non-randomized, worldwide, multi-center trial. A maximum of 1300 subjects were to be implanted at a maximum of 40 sites in the US, Europe and Canada. The trial includes male and female patients of legal age to provide informed consent in the country where they enrolled in the trial, requiring replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic valve. Subjects are followed out to 5 years, and select sites follow subjects out to 12 years. Enrollment closed on 14Jul2017 for all valve sizes. Enrollment was reopened in Apr2019 for the 29mm valve size at a subset of US and Canadian sites to obtain greater patient numbers required by the FDA to support US commercial approval of this valve size. Enrollment for the 29mm valve size closed on 14Feb2023.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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. Left atrial appendage (LAA) ligation ii. CABG (coronary artery bypass grafting) iii. Patent foramen ovale (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
Exclusion Criteria
- •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
- •Acute Type A aortic dissection
- •Ventricular aneurysm
- •Porcelain aorta
- •Hostile mediastinum
- •Hypertrophic obstructive cardiomyopathy (HOCM)
Arms & Interventions
Model 400 aortic valve bioprosthesis
Intervention: Model 400 aortic valve bioprosthesis
Outcomes
Primary Outcomes
Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant
Time Frame: 1 year post-implant
Safety of the valve is evaluated by the time-related incidence of valve-related adverse events and death. The following valve-related adverse events are evaluated in this study: Thromboembolism, Thrombosis, Hemorrhage, Paravalvular leak (PVL), Endocarditis, Hemolysis, Structural valve deterioration, Non-structural dysfunction, Reintervention, Explant, and Death. A minimum of 15 participants per valve size are evaluated. The incidence rates will be used to summarize valve-related adverse events and death.
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year
Time Frame: Discharge (up to 30 days), 3-6 months, and 1 year post-implant
At each timepoint, a minimum of 15 participants per valve size evaluated for change in New York Heart Association (NYHA) functional classification from baseline to 1 year post-procedure. Measure Description: Cardiac Disease with Functional Classes (lower value is more desirable than higher value) I - No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. II - Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. III - Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. IV - Symptoms of heart failure at rest. Any physical activity causes further discomfort.
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 1 Year
Time Frame: Measured at discharge (up to 30 days), 3-6 months, and 1 year post-implant
A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. The peak pressure gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury.
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 1 Year Post-procedure
Time Frame: Discharge (up to 30 days), 3-6 months, 1 year post-implant
A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. The effective orifice area (EOA) is measured as the minimal cross-sectional area of the blood flow downstream of the aortic valve.
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 1 Year Post-implant
Time Frame: Discharge (up to 30 days), 3-6 months, and 1 year post-implant
A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory for effective orifice area index (EOAI = EOA/BSA) Effective orifice area index is equal to the effective orifice area (EOA) in cm\^2 divided by body surface area (BSA) in m\^2. The achievement criterion for the effective orifice area index (EOAI) is defined to be ≥0.6 cm\^2/m\^2 12 months after the procedure. This criterion is in accordance with the definition of severe aortic stenosis in the American College of Cardiology (ACC) / American Heart Association (AHA) guidelines for the management of valvular heart disease.
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 1 Year Post-implant
Time Frame: Discharge (up to 30 days), 3-6 months, and 1 year post-implant
A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The mean pressure gradient is the average flow of blood through the aortic valve measured in millimeters of mercury.
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 1 Year Post-implant
Time Frame: Discharge (up to 30 days), 3-6 months, and 1 year post-implant
A minimum of 15 participants per valve size will have performance index (L/Min) measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The performance index is the measurement of the effective orifice area divided by the native orifice area.
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 1 Year Post-implant
Time Frame: Discharge (up to 30 days), 3-6 months, and 1 year post-implant
Cardiac output is the amount of blood pumped by the heart per minute. A minimum of 15 participants per valve size were evaluated for this outcome measure by transthoracic echocardiography technique and assessed by an independent core laboratory.
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 1 Year Post-implant
Time Frame: Discharge (up to 30 days), 3-6 months, and 1 year post-implant
A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The cardiac index is an assessment of the cardiac output based on a patient's size measured by dividing the cardiac output by the patient's body's surface area.
Secondary Outcomes
- Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death Annually Through 5 Years Post-implant(Annually, at years 2, 3, 4, and 5 post-implant)
- Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 5 Years Post-implant(Annually, at years 2, 3, 4, and 5 post-implant)
- Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 5 Years Post-implant(Annually, at years 2, 3, 4, and 5 post-implant)
- Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 5 Years Post-implant(Annually, at years 2, 3, 4, and 5 post-implant)
- Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 5 Years Post-implant(Annually, at years 2, 3, 4, and 5 post-implant)
- Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 5 Years Post-procedure(Annually, at years 2, 3, 4, and 5 post-implant)
- Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 5 Years Post-implant(Annually, at years 2, 3, 4, and 5 post-implant)
- Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 5 Years Post-implant(Annually, at years 2, 3, 4, and 5 post-implant)
- Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 5 Years Post-implant(Annually, at years 2, 3, 4, and 5 post-implant)