Avalus Ultra Post-Approval Study (PAS)
NCT Number: NCT06506903
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Aortic Valve Disease
Interventions: DEVICE: Medtronic Avalus Ultra
Sponsor: Medtronic Cardiac Surgery
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2026-11

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.

Primary Outcome Measures: Time-related incidence of adverse events and death through 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., 30 days and 1 year post-procedure|Evaluation of Mean Pressure Gradient (mmHg) through 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., 30 days and 1 year post-procedure|Evaluation of Effective Orifice Area (cm^2) through 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., 30 days and 1 year post-procedure|Change in heart failure status based on NYHA functional classification from baseline through 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., 30 days and 1 year post-procedure|Implanted valve size compared to pre-operative annulus dimensions on Multi-Detector Computed Tomography (MDCT), 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., 1 year post-procedure|Characterization of post-operative stent deformation on Multi-Detector Computed Tomography (MDCT), 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., 1 year post-procedure