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Harmony TPV Post-Approval Study

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

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.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    0 and up

Participation Criteria

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

Study Location

University of Alberta Hospital
University of Alberta Hospital
Edmonton, Alberta
Canada

Contact Study Team

Primary Contact

Anoop Mathew, MD

Study Sponsored By
Medtronic Cardiovascular
Participants Required
More Information
Study ID: NCT05077774