Trial Purpose and Description
The purpose of this study is to evaluate the safety and effectiveness of the Harmony TPV system.
The primary objective of this study is to demonstrate the safety and effectiveness of the Harmony¿ TPV system as measured by freedom from procedure or device‐related mortality at 30 days and percentage of subjects with acceptable hemodynamic function at 6 months.
- Subject has pulmonary regurgitation
- Subject has clinical indication for surgical placement of an RV-PA conduit or bioprosthetic pulmonary valve
- 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
Dates: 03/17/2017 - 12/31/2018
Last Updated: 02/22/2018
Study HIC#: 2000020113