Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
190 participants
INTERVENTIONAL
2024-11-20
2026-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Avalus Ultra
Avalus Ultra bioprosthesis: sizes 19mm, 21mm, 23mm, 25mm, 27mm, and 29mm
Medtronic Avalus Ultra
Surgical aortic valve replacement with the Medtronic Avalus Ultra bioprosthesis for management of aortic stenosis and regurgitation.
Interventions
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Medtronic Avalus Ultra
Surgical aortic valve replacement with the Medtronic Avalus Ultra bioprosthesis for management of aortic stenosis and regurgitation.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Medtronic Cardiac Surgery
INDUSTRY
Responsible Party
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Principal Investigators
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Juan Crestanello, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Bo Yang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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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
St. Joseph's Hospital Health Center
Syracuse, New York, United States
UH Cleveland Medical Center
Cleveland, Ohio, United States
ProMedica Toledo Hospital
Toledo, Ohio, United States
UPMC Presbyterian
Pittsburgh, Pennsylvania, United States
Heart Hospital of Austin
Austin, Texas, United States
CHI Saint Lukes Health - Baylor Saint Lukes Medical Center
Houston, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Swedish Medical Center Cherry Hill
Seattle, Washington, United States
Countries
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Other Identifiers
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MDT23007
Identifier Type: -
Identifier Source: org_study_id