Results of the phase I food and drug administration clinical trial of duct-occlud device occlusion of patent ductus arteriosus.
The purpose of this study was to evaluate the safety and the efficacy of transcatheter patent ductus arteriosus (PDA) occlusion with the Duct-Occlud device. Six centers participated in this phase I U.S. Food and Drug Administration-approved clinical trial with investigational device exemption. Patients with restrictive PDA (less than 4-mm minimum diameter) were eligible for the study. Sixty-two patients were enrolled. Forty-eight patients had successful implantation of Duct-Occlud devices. Patient follow-up evaluations were conducted at hospital discharge and after 2 and 12 months. At discharge and after 1 year, all patients had clinical PDA closure. Closure assessed by color flow Doppler was 55% at discharge, 88% at 2 months, and 94% at 1 year. There were no complications related to implantation or noted in follow-up evaluations. The Duct-Occlud device is safe and efficacious for the closure of small- to moderate-size patent ductus arteriosus.
Moore
J W
JW
Heart Center for Children, St. Christopher's Hospital for Children, Philadelphia, PA 19134, USA. jwm32@drexel.edu
DiMeglio
D
D
Javois
A P
AP
Takahashi
M
M
Berdjis
F
F
Cheatham
J P
JP
D006328:Cardiac Catheterization / Q000295:instrumentation* / Q000379:methods; D004374:Ductus Arteriosus, Patent / Q000175:diagnosis / Q000628:therapy*; D004867:Equipment Design; D004869:Equipment Safety; D005500:Follow-Up Studies; D006801:Humans; D018579:Patient Selection; D018570:Risk Assessment; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration