The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study
Status: Active_not_recruiting
Location: See all (12) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Ronald Regan UCLA Medical Center
Los Angeles
Stanford University Medical Center
Palo Alto
Connecticut
Yale University
New Haven
Minnesota
Mayo Clinic
Rochester
Ohio
Nationwide Children's Hospital
Columbus
Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia
Texas
Texas Children's Hospital
Houston
Utah
Primary Children's Hospital
Salt Lake City
Washington
Seattle Children's Hospital
Seattle
Other Locations
Canada
The Hospital for Sick Children (SickKids)
Toronto
Toronto General Hospital
Toronto
Japan
National Cerebral and Cardiovascular Center
Suita
Time Frame
Start Date: 2017-01
Completion Date: 2031-02
Participants
Target number of participants: 86
Treatments
Other: Harmony TPV System
Intervention Device: Harmony Transcatheter Pulmonary Valves and Delivery Systems
Authors
Related Therapeutic Areas
Sponsors
Leads: Medtronic Heart Valves