Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
The Harmony Transcatheter Pulmonary Valve (TPV) System is indicated for use in the management of pediatric and adult congenital heart disease patients with severe pulmonary regurgitation (i.e., severe pulmonary regurgitation as determined by echocardiography and/or pulmonary regurgitant fraction ≥ 30% as determined by cardiac magnetic resonance imaging) who have a native or surgically-repaired right ventricular outflow tract and are clinically indicated for pulmonary valve replacement as judged by the medical team.
Eligibility Criteria
Inclusion Criteria: 1. Subject eligible to receive Harmony TPV System in conformity with Instructions for Use (IFU) and local regulations at time of study enrollment. 2. Subject or subject's parent(s)/legal guardian(s) must be willing and able to consent to participate in the study and will commit to completion of all follow-up requirements Exclusion Criteria: 1. Obstruction of the central veins. 2. Planned concomitant branch pulmonary artery stenting at time of implant. 3. Subjects previously treated with an RV-PA conduit or previously implanted bioprosthesis. 4. 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. 5. Planned implantation of the Harmony TPV in the left heart. 6. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation. 7. Pre-existing prosthetic heart valve or prosthetic ring in any position 8. Subject is pregnant as confirmed by a positive pregnancy test before