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Clinical Trials in Japan / NCT02979587
Active, not recruiting Not applicable

The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study

NCT02979587 · tracked via the Priya Life Science Japan tracker
Sponsor
Medtronic Heart Valves
Phase
Not applicable
Started
2017-01
Last updated
2025-09-19

Condition(s) studied

Congenital Heart DiseaseTetrology of FallotRVOT AnomalyPulmonary Regurgitation

Investigational drug(s) / intervention(s)

Harmony TPV System

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

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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

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)

FacilityCityRegionStatus
Ronald Regan UCLA Medical Center Los Angeles California
Stanford University Medical Center Palo Alto California
Yale University New Haven Connecticut
Mayo Clinic Rochester Minnesota
Nationwide Children's Hospital Columbus Ohio
The Children's Hospital of Philadelphia Philadelphia Pennsylvania
Texas Children's Hospital Houston Texas
Primary Children's Hospital Salt Lake City Utah
Seattle Children's Hospital Seattle Washington
The Hospital for Sick Children (SickKids) Toronto Ontario
Toronto General Hospital Toronto Ontario
National Cerebral and Cardiovascular Center Suita Osaka

Other trials for the same condition

An Observational Study to Learn More About How Safe Rivaroxaban is And How Well it Works in Children With Congenital Heart Disease Who Had a Heart Surgery Called the Fontan Procedure Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02979587 on ClinicalTrials.gov ↗ ← All trials in Japan