Harmony TPV Post-Approval Study

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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

Harmony TPV Post-Approval Study (Harmony PAS2)

Harmony TPV Post-Approval Study

Condition
Congenital Heart Disease
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham Hospital, Birmingham, Alabama, United States, 35233

Phoenix

Phoenix Children's, Phoenix, Arizona, United States, 85016

Los Angeles

Cedars Sinai Medical Center, Los Angeles, California, United States, 90048

Aurora

Children's Hospital Colorado, Aurora, Colorado, United States, 80045

Tampa

St. Joseph Children's Hospital, Tampa, Florida, United States, 33607

Oak Lawn

Advocate Christ Medical Center, Oak Lawn, Illinois, United States, 60453

Baltimore

The Johns Hopkins Hospital, Baltimore, Maryland, United States, 21287

Boston

Boston Children's Hospital, Boston, Massachusetts, United States, 02115

Ann Arbor

University of Michigan Health System, Ann Arbor, Michigan, United States, 48109

Saint Louis

Saint Louis Children's Hospital, Saint Louis, Missouri, United States, 63110

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Patient eligible to receive the Harmony TPV, meeting the indications for use criteria per current geography-specific device labeling at time of study enrollment
  • * Patient (or patient's legally authorized representative) is willing to consent to participate in the study
  • * Obstruction of the central veins
  • * Planned concomitant branch pulmonary artery stenting at time of implant
  • * Subject is pregnant at time of implant procedure
  • * Patients with previously treated with an RV-PA conduit or previously implanted bioprosthesis
  • * 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
  • * Planned implantation of the Harmony TPV in the left heart
  • * Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
  • * Pre-existing prosthetic heart valve or prosthetic ring in any position

Ages Eligible for Study

to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Medtronic Cardiovascular,

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

Study Record Dates

2035-03