Comparison of Two Pulmonary Valve Replacement Methods to Treat Tetralogy of Fallot

NACompletedINTERVENTIONAL
Enrollment

68

Participants

Timeline

Start Date

April 30, 2004

Primary Completion Date

August 31, 2011

Study Completion Date

August 31, 2011

Conditions
Tetralogy of FallotPulmonary Valve InsufficiencyVentricular Dysfunction, Right
Interventions
PROCEDURE

PVR plus RV remodeling

PVR and surgical RV remodeling, which includes bioprosthetic pulmonary valve insertion and resection of akinetic scarred areas on the anterior RV wall to reduce RV volume

PROCEDURE

Standard PVR

PVR alone, which includes bioprosthetic pulmonary valve insertion and, when present, resection of right ventricular outflow tract (RVOT) aneurysm

Trial Locations (1)

02115

Department of Cardiology, Children's Hospital Boston, Boston

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

Boston Children's Hospital

OTHER

NCT00112320 - Comparison of Two Pulmonary Valve Replacement Methods to Treat Tetralogy of Fallot | Biotech Hunter | Biotech Hunter