86
Participants
Start Date
January 31, 2017
Primary Completion Date
July 17, 2020
Study Completion Date
February 28, 2031
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."
The Children's Hospital of Philadelphia, Philadelphia
Nationwide Children's Hospital, Columbus
Mayo Clinic, Rochester
Texas Children's Hospital, Houston
Primary Children's Hospital, Salt Lake City
Ronald Regan UCLA Medical Center, Los Angeles
Stanford University Medical Center, Palo Alto
Seattle Children's Hospital, Seattle
Yale University, New Haven
The Hospital for Sick Children (SickKids), Toronto
Toronto General Hospital, Toronto
National Cerebral and Cardiovascular Center, Suita
Medtronic Heart Valves
INDUSTRY