The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study

About

Brief Summary

The purpose of this study is to further evaluate the safety and effectiveness of the Harmony™ TPV system. The Pivotal/CAS phases of the study have transitioned into a post-approval study to confirm the long-term functionality of transcatheter implantation of the Medtronic Harmony TPV.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 2

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

N/A

Maximum Age

N/A

Inclusion Criteria:

Subject has severe pulmonary regurgitation as assessed via echocardiography or CMR determined PR fraction >/= 30%
Subject has clinical indication for surgical placement of an RV-PA conduit or bioprosthetic pulmonary valve
Subject is willing to consent to participate

Exclusion Criteria:

Patients with right ventricular outflow tract obstruction (RVOTO) lesions surgically treated with an RV-to-PA conduit implant
RVOT anatomy or morphology that is unfavorable for device anchoring
Positive pregnancy test
Life expectancy of less than 1 year

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