Avalus Ultra Post-Approval Study (PAS)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Aortic Valve Disease
• Intervention / Treatment: Device: Medtronic Avalus Ultra

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.

• Study Type: Interventional
• Enrollment (Actual): 190
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Hartford Hospital
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida Shands
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Emory Saint Joseph's
    • Marietta, Georgia, United States, 30060
      • Wellstar Kennestone Hospital
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Health System - University Hospital
  • Minnesota
    • Rochester, Minnesota, United States, 55902
      • Mayo Clinic
  • New York
    • Syracuse, New York, United States, 13203
      • St. Joseph's Hospital Health Center
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • UH Cleveland Medical Center
    • Toledo, Ohio, United States, 43606
      • ProMedica Toledo Hospital
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Presbyterian
  • Texas
    • Austin, Texas, United States, 78756
      • Heart Hospital of Austin
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital
    • Houston, Texas, United States, 77030
      • CHI Saint Lukes Health - Baylor Saint Lukes Medical Center
  • Washington
    • Seattle, Washington, United States, 98122
      • Swedish Medical Center Cherry Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Avalus Ultra; Avalus Ultra bioprosthesis: sizes 19mm, 21mm, 23mm, 25mm, 27mm, and 29mm	Device: Medtronic Avalus Ultra; Surgical aortic valve replacement with the Medtronic Avalus Ultra bioprosthesis for management of aortic stenosis and regurgitation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time-related incidence of adverse events and death through 1 year post-procedure	Safety of the valve is evaluated by the time-related incidence of valve-related adverse events and death. The following valve-related adverse events are evaluated in this study: thromboembolism, valve thrombosis, hemorrhage, paravalvular leak, endocarditis, structural valve deterioration, non-structural valve dysfunction, reintervention, death. This safety endpoint is descriptive, and no statistical hypothesis testing will be performed. The primary analysis of safety endpoint events will occur once all implanted participants have completed their 1 year post-procedure visit or exited the study.	30 days and 1 year post-procedure
Evaluation of Mean Pressure Gradient (mmHg) through 1 year post-procedure	Mean pressure gradient is evaluated by transthoracic echocardiography technique as the average flow of blood through the aortic valve measured in millimeters of mercury. This effectiveness endpoint is descriptive, and will be summarized as with continuous data. No statistical hypothesis testing will be performed. The primary analysis of effectiveness endpoint events will occur once all implanted participants have completed their 1 year post-procedure visit or exited.	30 days and 1 year post-procedure
Evaluation of Effective Orifice Area (cm^2) through 1 year post-procedure	Effective Orifice Area (EOA) is assessed by transthoracic echocardiography technique and is measured as the minimal cross-sectional area of the blood flow downstream of the aortic valve. This effectiveness endpoint is descriptive, and will be summarized as with continuous data. No statistical hypothesis testing will be performed. The primary analysis of effectiveness endpoint events will occur once all implanted participants have completed their 1 year post-procedure visit or exited.	30 days and 1 year post-procedure
Change in heart failure status based on NYHA functional classification from baseline through 1 year post-procedure	The change of the New York Heart Association (NYHA) functional classification at 30 days and 1 year from baseline will be used to evaluate the change heart failure status. The primary analysis will occur once all implanted participants have completed their 1 year visit or exited; no statistical hypothesis testing will be performed. Measure Description: Cardiac Disease with Functional Classes (lower value is more desirable than higher value) I - No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. II - Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. III - Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. IV - Symptoms of heart failure at rest. Any physical activity causes further discomfort.	30 days and 1 year post-procedure
Implanted valve size compared to pre-operative annulus dimensions on Multi-Detector Computed Tomography (MDCT)	This effectiveness endpoint is descriptive, and no statistical hypothesis testing will be performed. The primary analysis of effectiveness endpoint events will occur once all implanted participants have completed their 1 year post-procedure visit or exited.	1 year post-procedure
Characterization of post-operative stent deformation on Multi-Detector Computed Tomography (MDCT)	This effectiveness endpoint is descriptive, and no statistical hypothesis testing will be performed. The primary analysis of effectiveness endpoint events will occur once all implanted participants have completed their 1 year post-procedure visit or exited.	1 year post-procedure

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Surgery
• Investigators: Principal Investigator: Juan Crestanello, MD, Mayo Clinic; Principal Investigator: Bo Yang, MD, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: July 2, 2024
• First Submitted That Met QC Criteria: July 16, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Aortic Valve Disease
• Other Study ID Numbers: MDT23007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No