ACTIVE_NOT_RECRUITING

Harmony TPV Post-Approval Study

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Conditions

Congenital Heart DiseaseTetrology of FallotRVOT AnomalyPulmonary Regurgitation

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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 functionality of transcatheter implantation of the Medtronic Harmony Transcatheter Pulmonary Valve (TPV) achieved by real-world implanters.

Official Title

Harmony TPV Post-Approval Study (Harmony PAS2)

Quick Facts

Study Start:2021-10-25
Study Completion:2035-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05077774

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:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient eligible to receive the Harmony TPV, meeting the indications for use criteria per current geography-specific device labeling at time of study enrollment
  2. * Patient (or patient's legally authorized representative) is willing to consent to participate in the study
  1. * Obstruction of the central veins
  2. * Planned concomitant branch pulmonary artery stenting at time of implant
  3. * Subject is pregnant at time of implant procedure
  4. * Patients with previously treated with an RV-PA conduit or previously implanted bioprosthesis
  5. * A major or progressive non-cardiac disease (e.g. liver failure, renal failure, cancer) that results in a life expectancy of less than one year
  6. * Planned implantation of the Harmony TPV in the left heart
  7. * Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
  8. * Pre-existing prosthetic heart valve or prosthetic ring in any position

Contacts and Locations

Principal Investigator

David Balzer, MD
PRINCIPAL_INVESTIGATOR
St. Louis Children's Hospital

Study Locations (Sites)

University of Alabama at Birmingham Hospital
Birmingham, Alabama, 35233
United States
Cedars Sinai Medical Center
Los Angeles, California, 90048
United States
Children's Hospital Colorado
Aurora, Colorado, 80045
United States
St. Joseph Children's Hospital
Tampa, Florida, 33607
United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
United States
Boston Children's Hospital
Boston, Massachusetts, 02115
United States
University of Michigan Health System
Ann Arbor, Michigan, 48109
United States
Saint Louis Children's Hospital
Saint Louis, Missouri, 63110
United States
Children's Hospital & Medical Center
Omaha, Nebraska, 68114
United States
The Mount Sinai Hospital
New York, New York, 10029
United States
Children's Hospital New York - Presbyterian
New York, New York, 10032
United States
Atrium Health Levine Children's Hospital
Charlotte, North Carolina, 28203
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Medical City Children's Hospital
Dallas, Texas, 75230
United States
University of Virginia
Charlottesville, Virginia, 22903
United States

Collaborators and Investigators

Sponsor: Medtronic Cardiovascular

  • David Balzer, MD, PRINCIPAL_INVESTIGATOR, St. Louis Children's Hospital

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 Date2021-10-25
Study Completion Date2035-03

Study Record Updates

Study Start Date2021-10-25
Study Completion Date2035-03

Terms related to this study

Additional Relevant MeSH Terms

  • Congenital Heart Disease
  • Tetrology of Fallot
  • RVOT Anomaly
  • Pulmonary Regurgitation