The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study

NAActive, not recruitingINTERVENTIONAL
Enrollment

86

Participants

Timeline

Start Date

January 31, 2017

Primary Completion Date

July 17, 2020

Study Completion Date

February 28, 2031

Conditions
Congenital Heart DiseaseTetrology of FallotRVOT AnomalyPulmonary Regurgitation
Interventions
DEVICE

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."

Trial Locations (12)

19104

The Children's Hospital of Philadelphia, Philadelphia

43215

Nationwide Children's Hospital, Columbus

55902

Mayo Clinic, Rochester

77030

Texas Children's Hospital, Houston

84113

Primary Children's Hospital, Salt Lake City

90095

Ronald Regan UCLA Medical Center, Los Angeles

94304

Stanford University Medical Center, Palo Alto

98105

Seattle Children's Hospital, Seattle

06510

Yale University, New Haven

M5G 1X8

The Hospital for Sick Children (SickKids), Toronto

M5G 2C4

Toronto General Hospital, Toronto

565-8565

National Cerebral and Cardiovascular Center, Suita

All Listed Sponsors
lead

Medtronic Heart Valves

INDUSTRY