Harmony TPV Post-Approval Study

ID#: NCT05077774

Age: Birth - 66+

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: October 25, 2021

End Date: March 01, 2033

Contact Information:
Michelle Vanney
763-514-4000
Harmony Clinical Study Central Email
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:

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
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