Clinical trial NCT06506903: Avalus Ultra Post-Approval Study (PAS)
Official title: Avalus Ultra Post-Approval Study (PAS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aortic Valve Disease
Lead sponsor: Medtronic Cardiac Surgery
Sponsor class: INDUSTRY
First posted: 2024-07-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time-related incidence of adverse events and death through 1 year post-procedure
timeFrame: 30 days and 1 year post-procedure
measure: Evaluation of Mean Pressure Gradient (mmHg) through 1 year post-procedure
timeFrame: 30 days and 1 year post-procedure
measure: Evaluation of Effective Orifice Area (cm^2) through 1 year post-procedure
timeFrame: 30 days and 1 year post-procedure
measure: Change in heart failure status based on NYHA functional classification from baseline through 1 year post-procedure
timeFrame: 30 days and 1 year post-procedure
measure: Implanted valve size compared to pre-operative annulus dimensions on Multi-Detector Computed Tomography (MDCT)
timeFrame: 1 year post-procedure
measure: Characterization of post-operative stent deformation on Multi-Detector Computed Tomography (MDCT)
timeFrame: 1 year post-procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Gainesville
country: United States
facility: University of Florida Shands
state: Florida
city: Atlanta
country: United States
facility: Emory Saint Joseph's
state: Georgia
city: Marietta
country: United States
facility: WellStar Kennestone Hospital
state: Georgia
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Ann Arbor
country: United States
facility: University of Michigan Health System - University Hospital
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Syracuse
country: United States
facility: St. Joseph's Hospital Health Center
state: New York
city: Toledo
country: United States
facility: ProMedica Toledo Hospital
state: Ohio
city: Austin
country: United States
facility: Heart Hospital of Austin
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Seattle
country: United States
facility: Swedish Medical Center Cherry Hill
state: Washington
Study officials:
affiliation: Mayo Clinic
name: Juan Crestanello, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Bo Yang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: