Avalus Ultra Post-Approval Study (PAS)

Launched by MEDTRONIC CARDIAC SURGERY · Jul 16, 2024

Keywords

ClinConnect Summary

The Avalus Ultra Post-Approval Study (PAS) is a clinical trial that aims to evaluate the safety and effectiveness of a new heart valve called the Medtronic Avalus Ultra bioprosthesis for patients with aortic valve disease. This condition can involve narrowing (stenosis) or leaking (regurgitation) of the aortic valve, and the study is looking for patients who may need to have their damaged valve replaced. The trial is currently recruiting participants aged 65 to 74, regardless of gender, who are stable and willing to return for follow-up visits after their procedure.

To be eligible for the study, participants should have moderate or more severe aortic stenosis or regurgitation and require valve replacement. They should also not have significant issues with other heart valves or serious health problems that could complicate surgery. If eligible, participants can expect to undergo the valve replacement procedure and will be closely monitored for safety and effectiveness during follow-up appointments. This study is important because it will help gather more information on how well this new valve works and its potential benefits for patients with aortic valve disease.

Gender

ALL

Eligibility criteria

• • 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