Safety and Effectiveness of the Nit-Occlud® Lê VSD Spiral Coil System

NACompletedINTERVENTIONAL
Enrollment

103

Participants

Timeline

Start Date

October 31, 2006

Primary Completion Date

August 31, 2012

Study Completion Date

May 31, 2017

Conditions
Heart Septal Defects, Ventricular
Interventions
DEVICE

transcatheter implantation of a VSD occluder (Nitinol coil)

transcatheter implantation, by first performing a arterial-venous loop through the defect

Trial Locations (6)

13353

Dept. Congem.Heart Defects, Deutsches Herzzentrum, Berlin

20246

Dept. Paediatric Cardiology, Univ. Hospital Hamburg, Hamburg

31096

Meyer Children's Hospital, Rambam Med. Center, Haifa

35390

Univ.Klinikum, Zentrum fuer Kinderheilkunde, Giessen

60389

Cardio-Vascular Centre, Sankt Kathrinen, Frankfurt

81377

Dept. Paediatric Cardiology, Univ. Clinic Grosshadern, Munich

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Aix Scientifics

INDUSTRY

lead

pfm medical gmbh

INDUSTRY