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Clinical Trials in the USA / NCT05077774
Active, not recruiting Not applicable

Harmony TPV Post-Approval Study

NCT05077774 · tracked via the Priya Life Science USA tracker
Sponsor
Medtronic Cardiovascular
Phase
Not applicable
Started
2021-10-25
Last updated
2026-06-02

Condition(s) studied

Congenital Heart DiseaseTetrology of FallotRVOT AnomalyPulmonary Regurgitation

Investigational drug(s) / intervention(s)

Harmony TPV System

Harmony TPV System: Harmony Transcatheter Pulmonary Valve (sizes 22 mm and 25 mm) and Harmony Delivery Catheter System (DCS)

Study summary

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.

Eligibility

Sex
ALL
Min age
Max age
Healthy volunteers
No
Inclusion 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 Exclusion Criteria: * 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

Primary outcome measure(s)

Trial sites (20)

FacilityCityRegionStatus
University of Alabama at Birmingham Hospital Birmingham Alabama
Cedars Sinai Medical Center Los Angeles California
Children's Hospital Colorado Aurora Colorado
St. Joseph Children's Hospital Tampa Florida
Advocate Christ Medical Center Oak Lawn Illinois
Boston Children's Hospital Boston Massachusetts
University of Michigan Health System Ann Arbor Michigan
Saint Louis Children's Hospital St Louis Missouri
Children's Hospital & Medical Center Omaha Nebraska
The Mount Sinai Hospital New York New York
Children's Hospital New York - Presbyterian New York New York
Atrium Health Levine Children's Hospital Charlotte North Carolina
Duke University Medical Center Durham North Carolina
Cincinnati Children's Hospital Medical Center Cincinnati Ohio
Cleveland Clinic Cleveland Ohio
UPMC Children's Hospital of Pittsburgh Pittsburgh Pennsylvania
Medical University of South Carolina Charleston South Carolina
Medical City Children's Hospital Dallas Texas
University of Virginia Charlottesville Virginia
University of Alberta Hospital Edmonton Alberta
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05077774 on ClinicalTrials.gov ↗ ← All trials in the USA