Avalus Ultra Post-Approval Study (PAS)

NCT06506903 | Active Not Recruiting FDA Device

• 1 other identifier: MDT23007
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 15

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.

Conditions

Aortic Valve Disease

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

Avalus Ultra

EXPERIMENTAL

Avalus Ultra bioprosthesis: sizes 19mm, 21mm, 23mm, 25mm, 27mm, and 29mm

Device: Medtronic Avalus Ultra

Interventions

Medtronic Avalus Ultra DEVICE

Surgical aortic valve replacement with the Medtronic Avalus Ultra bioprosthesis for management of aortic stenosis and regurgitation.

Avalus Ultra

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Surgery: lead

Study Sites (15)

Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

University of Florida Shands

Gainesville, Florida, 32610, United States

Location

Emory Saint Joseph's

Atlanta, Georgia, 30342, United States

Location

WellStar Kennestone Hospital

Marietta, Georgia, 30060, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

University of Michigan Health System - University Hospital

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

St. Joseph's Hospital Health Center

Syracuse, New York, 13203, United States

Location

UH Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

ProMedica Toledo Hospital

Toledo, Ohio, 43606, United States

Location

UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

Location

Heart Hospital of Austin

Austin, Texas, 78756, United States

Location

CHI Saint Lukes Health - Baylor Saint Lukes Medical Center

Houston, Texas, 77030, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Swedish Medical Center Cherry Hill

Seattle, Washington, 98122, United States

Location

MeSH Terms

Conditions

Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Juan Crestanello, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Bo Yang, MD, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 18, 2024
• Study Start: November 20, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

US (15)