The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study

Condition(s) studied

Investigational drug(s) / intervention(s)

Harmony TPV System: The Harmony™ TPV (Model NTPV0022) is comprised of a 22mm porcine pericardium valve, sewn to a polyester-covered nitinol frame. The Harmony TPV 25 and mTPV 25 (Model HTPV254952 and HTPV254252, respectively) is comprised of a 25mm porcine pericardium valve, sewn to a polyester covered asymmetrical hourglass nitinol frame with larger diameter inflow and outflow as well as shorter length compared to TPV 22 (Harmony TPV 25 Model HTPV254952 is not applicable for Continued Clinical Experience). The Harmony Delivery System (DS) for the TPV 22, TPV 25, and mTPV 25 (NTPVDS0022 and HTPVDS0025) are all 25 Fr delivery systems using a coil loading catheter.

Study 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.

Eligibility

Primary outcome measure(s)

• Freedom From Procedure- or Device-related Mortality at 30 Days. — 30 days
  The primary safety endpoint is point estimate of freedom from procedure or device-related mortality rate at 30 days post procedure.
• Number of Participants With Acceptable Hemodynamic Function Composite at 6 Months — 6 months
  Defined as: * Mean RVOT gradient as measured by continuous-wave Doppler ≤40 mmHg -AND- * Pulmonary regurgitant fraction as measured by magnetic resonance imaging \<20%

Trial sites (12)

Other trials for the same condition