Avalus Ultra Post-Approval Study (PAS)
- Conditions
- Aortic Valve Disease
- Interventions
- Device: Medtronic Avalus Ultra
- Registration Number
- NCT06506903
- Lead Sponsor
- Medtronic Cardiac Surgery
- Brief Summary
The purpose of this study is to characterize the safety and effectiveness of the Medtronic Avalus Ultra aortic valve bioprosthesis in patients with aortic valve disease.
- Detailed Description
A prospective, multi-center, single-arm, interventional, non-randomized, post-market study to characterize the safety and effectiveness of the Medtronic Avalus Ultra aortic valve bioprosthesis in patients with aortic valve disease. Approximately 150 subjects in the United States will be implanted and followed through one year post-procedure.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Avalus Ultra Medtronic Avalus Ultra Avalus Ultra bioprosthesis: sizes 19mm, 21mm, 23mm, 25mm, 27mm, and 29mm
- Primary Outcome Measures
Name Time Method Time-related incidence of adverse events and death through 1 year post-procedure 30 days and 1 year post-procedure 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, valve thrombosis, hemorrhage, paravalvular leak, endocarditis, structural valve deterioration, non-structural valve dysfunction, reintervention, death. This safety endpoint is descriptive, and no statistical hypothesis testing will be performed. The primary analysis of safety endpoint events will occur once all implanted participants have completed their 1 year post-procedure visit or exited the study.
Evaluation of Effective Orifice Area (cm^2) through 1 year post-procedure 30 days and 1 year post-procedure Effective Orifice Area (EOA) is assessed by transthoracic echocardiography technique and is measured as the minimal cross-sectional area of the blood flow downstream of the aortic valve. This effectiveness endpoint is descriptive, and will be summarized as with continuous data. No statistical hypothesis testing will be performed. The primary analysis of effectiveness endpoint events will occur once all implanted participants have completed their 1 year post-procedure visit or exited.
Implanted valve size compared to pre-operative annulus dimensions on Multi-Detector Computed Tomography (MDCT) 1 year post-procedure This effectiveness endpoint is descriptive, and no statistical hypothesis testing will be performed. The primary analysis of effectiveness endpoint events will occur once all implanted participants have completed their 1 year post-procedure visit or exited.
Characterization of post-operative stent deformation on Multi-Detector Computed Tomography (MDCT) 1 year post-procedure This effectiveness endpoint is descriptive, and no statistical hypothesis testing will be performed. The primary analysis of effectiveness endpoint events will occur once all implanted participants have completed their 1 year post-procedure visit or exited.
Evaluation of Mean Pressure Gradient (mmHg) through 1 year post-procedure 30 days and 1 year post-procedure Mean pressure gradient is evaluated by transthoracic echocardiography technique as the average flow of blood through the aortic valve measured in millimeters of mercury. This effectiveness endpoint is descriptive, and will be summarized as with continuous data. No statistical hypothesis testing will be performed. The primary analysis of effectiveness endpoint events will occur once all implanted participants have completed their 1 year post-procedure visit or exited.
Change in heart failure status based on NYHA functional classification from baseline through 1 year post-procedure 30 days and 1 year post-procedure The change of the New York Heart Association (NYHA) functional classification at 30 days and 1 year from baseline will be used to evaluate the change heart failure status. The primary analysis will occur once all implanted participants have completed their 1 year visit or exited; no statistical hypothesis testing will be performed.
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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
Swedish Medical Center Cherry Hill
🇺🇸Seattle, Washington, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
University of Florida Shands
🇺🇸Gainesville, Florida, United States
Emory Saint Joseph's
🇺🇸Atlanta, Georgia, United States
WellStar Kennestone Hospital
🇺🇸Marietta, Georgia, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
University of Michigan Health System - University Hospital
🇺🇸Ann Arbor, Michigan, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
ProMedica Toledo Hospital
🇺🇸Toledo, Ohio, United States
St. Joseph's Hospital Health Center
🇺🇸Syracuse, New York, United States
Heart Hospital of Austin
🇺🇸Austin, Texas, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States