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

Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional

Official Title: International Multicentre Clinical Device Investigation on Safety and Effectiveness of the Nit-Occlud® Lê VSD Spiral Coil System for VSD Occlusion Developed by Pfm AG, Cologne

Brief Summary: The Ventricular septal defect (VSD) is the most common of all congenital cardiac malformations. By modifying the Nit-Occlud® PDA Device the Nit-Occlud® Lê VSD Spiral System was designed. as a percutaneous, transcatheter device for occlusion of (peri)membranous and muscular ventricular septum defects (VSD) with a spiral coil. In this clinical investigation feasibility, safety and performance of the new cardiac occluder will be evaluated in accordance with European and US regulations. The study data will be compared to performance criteria for VSD, which are deduced analogue to the published specific Objective Performance Criteria (OPCs) for PDAs. The first part of the study has been performed in three clinical centres in Germany. For the second part in April 2009 four additional clinical centres in Germany, Israel, Italy and Spain were included.

Detailed Summary:
Sponsor: pfm medical ag

Current Primary Outcome: a set of Performance Criteria (PC) deduced for VSD analogue to the set of Objective Performance Criteria (OPC) of the 'Multiorganization Advisory Panel to FDA for Pediatric Cardiovascular Devices' for PDAs [ Time Frame: one year ]

Original Primary Outcome: a set of Performance Criteria (PC) deduced for VSD analogue to the set of Objective Performance Criteria (OPC) of the 'Multiorganization Advisory Panel to FDA for Pediatric Cardiovascular Devices' for PDAs

Current Secondary Outcome: -- as a set of Performance Criteria is used, no additional sec. endpoints are defined. --

Original Secondary Outcome:

Information By: pfm medical ag

Dates:
Date Received: October 19, 2006
Date Started: October 2006
Date Completion: August 2016
Last Updated: August 22, 2012
Last Verified: August 2012