Status:
ACTIVE_NOT_RECRUITING
Avalus Ultra Post-Approval Study (PAS)
Lead Sponsor:
Medtronic Cardiac Surgery
Conditions:
Aortic Valve Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 pati...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Subjects must meet the following criteria to be included in the study:
- 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
- Subject is geographically stable and willing to return to the implanting site for all follow-up visits
- Subject is of legal age to provide informed consent
- 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:
- 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
- Subject has had a previous implant and then explant of the Avalus Ultra aortic valve bioprosthesis within the Avalus Ultra Post-Approval Study
- Subject presents with active endocarditis, active myocarditis, or other systemic infection
- Subject has a known hypersensitivity to contrast media that cannot be adequately premedicated
- Subject has a known hypersensitivity to platinum, iridium, or tantalum
- 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)
- 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
- Subject has renal failure, defined by dialysis therapy or glomerular filtration rate (GFR) \<30 mL/min/1.73 m2
- Subject has active or untreated hyperparathyroidism
- Subject is participating in another investigational device or drug trial (not including registries)
- Subject is pregnant, lactating, or planning to become pregnant during the study period
- Subject has a documented history of substance (drug or alcohol) abuse
- Subject has greater than mild mitral valve regurgitation or greater than mild tricuspid valve regurgitation as assessed by echocardiography
- Subject has systolic ejection fraction (EF) \<20% as assessed by echocardiography
- Subject has Grade IV diastolic dysfunction
- Subject has documented bleeding diatheses
- Subject has had an acute preoperative neurological deficit or myocardial infarction and has not returned to baseline or stabilized ≥30 days prior to implant
- Subject requires emergency surgery
Exclusion
Key Trial Info
Start Date :
November 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2026
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT06506903
Start Date
November 20 2024
End Date
November 1 2026
Last Update
December 17 2025
Active Locations (15)
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1
Hartford Hospital
Hartford, Connecticut, United States, 06106
2
University of Florida Shands
Gainesville, Florida, United States, 32610
3
Emory Saint Joseph's
Atlanta, Georgia, United States, 30342
4
WellStar Kennestone Hospital
Marietta, Georgia, United States, 30060