The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study

The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study

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.

The continued clinical experience addendum is a prospective, multi-center, non-randomized, interventional study to evaluate the safety and effectiveness of the Harmony TPV system. All implanted subjects will receive the Harmony TPV 22 or Harmony mTPV 25 device. This phase allows up to 45 subjects implanted with TPV 22 in the United States and Canada, and up to 84 subjects implanted with mTPV 25 in the United States.

The Post Approval Phase (PAS) addendum is a prospective, multi-center, non-randomized, post-market study to evaluate the safety and effectiveness of the Harmony TPV system in the United States. All implanted subjects have been implanted with the Harmony TPV 22 or Harmony mTPV 25 device during the pivotal or CAS phase of the study. The PAS addendum extends follow-up from five years to ten years for consenting subjects.

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