ACTIVE_NOT_RECRUITING

Avalus Ultra Post-Approval Study (PAS)

Talk to us

Conditions

Aortic Valve Disease

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Avalus Ultra Post-Approval Study (PAS)

Quick Facts

Study Start:2024-11-20
Study Completion:2026-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06506903

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Juan Crestanello, MD
PRINCIPAL_INVESTIGATOR
Mayo Clinic
Bo Yang, MD, PhD
PRINCIPAL_INVESTIGATOR
University of Michigan

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Medtronic Cardiac Surgery

  • Juan Crestanello, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic
  • Bo Yang, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-20
Study Completion Date2026-11

Study Record Updates

Study Start Date2024-11-20
Study Completion Date2026-11

Terms related to this study

Additional Relevant MeSH Terms

  • Aortic Valve Disease