Aortic Valve Disease
Conditions
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.
Interventions
DEVICEMedtronic Avalus Ultra
Surgical aortic valve replacement with the Medtronic Avalus Ultra bioprosthesis for management of aortic stenosis and regurgitation.
Sponsors
Medtronic Cardiac Surgery
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects must meet the following criteria to be included in the study: 1. Subject has moderate or greater aortic stenosis or regurgitation, and there is a 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: * Atrial fibrillation (AF) ablation * Ascending aortic aneurysm or dissection repair or replacement, with or without circulatory arrest * Coronary artery bypass graft (CABG) * Surgical management of the left atrial appendage (LAA) * Patent foramen ovale (PFO) closure * Resection of a sub-aortic membrane not requiring myectomy 2. Subject is geographically stable and willing to return to the implanting site for all follow-up visits 3. Subject is of legal age to provide informed consent 4. Subject has been adequately informed of risks and requirements of the study and is willing and able to provide informed consent for participation in the study
Exclusion criteria
Subjects who meet any of the following criteria will not be eligible for participation in the study: 1. Subject has a pre-existing prosthetic valve or annuloplasty device in another position or requires replacement or repair of the mitral, pulmonary, or tricuspid valve 2. Subject has had a previous implant and then explant of the Avalus Ultra aortic valve bioprosthesis within the Avalus Ultra Post-Approval Study 3. Subject presents with active endocarditis, active myocarditis, or other systemic infection 4. Subject has a known hypersensitivity to contrast media that cannot be adequately premedicated 5. Subject has a known hypersensitivity to platinum, iridium, or tantalum 6. Subject has an anatomical abnormality that would increase surgical risk of morbidity or mortality, including: * Acute Type A aortic dissection * Ventricular aneurysm * Porcelain aorta * Hostile mediastinum * Hypertrophic obstructive cardiomyopathy * Documented pulmonary hypertension (systolic \>60mmHg) 7. Subject has a non-cardiac major or progressive disease with a life expectancy of less than 1 year. These conditions include but are not limited to: * Child-Pugh Class C liver disease * Terminal cancer * End-stage lung disease 8. Subject has renal failure, defined by dialysis therapy or glomerular filtration rate (GFR) \<30 mL/min/1.73 m2 9. Subject has active or untreated hyperparathyroidism 10. Subject is participating in another investigational device or drug trial (not including registries) 11. Subject is pregnant, lactating, or planning to become pregnant during the study period 12. Subject has a documented history of substance (drug or alcohol) abuse 13. Subject has greater than mild mitral valve regurgitation or greater than mild tricuspid valve regurgitation as assessed by echocardiography 14. Subject has systolic ejection fraction (EF) \<20% as assessed by echocardiography 15. Subject has Grade IV diastolic dysfunction 16. Subject has documented bleeding diatheses 17. Subject has had an acute preoperative neurological deficit or myocardial infarction and has not returned to baseline or stabilized ≥30 days prior to implant 18. Subject requires emergency surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJuan Crestanello, MD
Mayo Clinic
PRINCIPAL_INVESTIGATORBo Yang, MD, PhD
University of Michigan
Outcome results
None listed