The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study

Trial ID or NCT#

NCT02979587

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study

Eligibility Criteria

Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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

Investigator(s)

Michael Ma
Assistant Professor of Cardiothoracic Surgery (Pediatric Cardiac Surgery)
Doff McElhinney