Harmony TPV Post-Approval Study

NAActive, not recruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

October 25, 2021

Primary Completion Date

October 31, 2025

Study Completion Date

March 31, 2035

Conditions
Congenital Heart DiseaseTetrology of FallotRVOT AnomalyPulmonary Regurgitation
Interventions
DEVICE

Harmony TPV System

Harmony Transcatheter Pulmonary Valve (sizes 22 mm and 25 mm) and Harmony Delivery Catheter System (DCS)

Trial Locations (20)

10029

The Mount Sinai Hospital, New York

10032

Children's Hospital New York - Presbyterian, New York

15224

UPMC Children's Hospital of Pittsburgh, Pittsburgh

22903

University of Virginia, Charlottesville

27710

Duke University Medical Center, Durham

28203

Atrium Health Levine Children's Hospital, Charlotte

29425

Medical University of South Carolina, Charleston

33607

St. Joseph Children's Hospital, Tampa

35233

University of Alabama at Birmingham Hospital, Birmingham

44195

Cleveland Clinic, Cleveland

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

48109

University of Michigan Health System, Ann Arbor

60453

Advocate Christ Medical Center, Oak Lawn

63110

Saint Louis Children's Hospital, St Louis

68114

Children's Hospital & Medical Center, Omaha

75230

Medical City Children's Hospital, Dallas

80045

Children's Hospital Colorado, Aurora

90048

Cedars Sinai Medical Center, Los Angeles

02115

Boston Children's Hospital, Boston

T6G 2B7

University of Alberta Hospital, Edmonton

Sponsors
All Listed Sponsors
lead

Medtronic Cardiovascular

INDUSTRY

NCT05077774 - Harmony TPV Post-Approval Study | Biotech Hunter | Biotech Hunter