Avalus Ultra Post-Approval Study (PAS)

Status: Active_not_recruiting
Location: See all (15) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

∙ 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

Locations
United States
Connecticut
Hartford Hospital
Hartford
Florida
University of Florida Shands
Gainesville
Georgia
Emory Saint Joseph's
Atlanta
WellStar Kennestone Hospital
Marietta
Illinois
Northwestern Memorial Hospital
Chicago
Michigan
University of Michigan Health System - University Hospital
Ann Arbor
Minnesota
Mayo Clinic
Rochester
New York
St. Joseph's Hospital Health Center
Syracuse
Ohio
UH Cleveland Medical Center
Cleveland
ProMedica Toledo Hospital
Toledo
Pennsylvania
UPMC Presbyterian
Pittsburgh
Texas
Heart Hospital of Austin
Austin
CHI Saint Lukes Health - Baylor Saint Lukes Medical Center
Houston
Houston Methodist Hospital
Houston
Washington
Swedish Medical Center Cherry Hill
Seattle
Time Frame
Start Date: 2024-11-20
Completion Date: 2026-11
Participants
Target number of participants: 190
Treatments
Experimental: Avalus Ultra
Avalus Ultra bioprosthesis: sizes 19mm, 21mm, 23mm, 25mm, 27mm, and 29mm
Related Therapeutic Areas
Sponsors
Leads: Medtronic Cardiac Surgery

This content was sourced from clinicaltrials.gov