Avalus Ultra Post-Approval Study (PAS)

Medtronic

Status

Enrolling

Conditions

Aortic Valve Disease

Treatments

Device: Medtronic Avalus Ultra

Study type

Interventional

Funder types

Industry

Identifiers

NCT06506903

MDT23007

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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