NCT00390702

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: pfm medical gmbh · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Septal Defects, Ventricular

Interventions

Type	Name	Description
DEVICE	transcatheter implantation of a VSD occluder (Nitinol coil)	transcatheter implantation, by first performing a arterial-venous loop through the defect

Timeline

• Start date: 2006-10-01
• Primary completion: 2012-08-01
• Completion: 2017-05-01
• First posted: 2006-10-20
• Last updated: 2018-11-07

Locations

6 sites across 2 countries: Germany, Israel