Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00390702
Status:
COMPLETED
Last Update Posted:
2018-11-07
First Post:
2006-10-19
Brief Title:
Safety and Effectiveness of the Nit-Occlud Lê VSD Spiral Coil System
Sponsor:
pfm medical gmbh
Organization:
pfm medical gmbh
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
pfm-012005
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 perimembranous 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 Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None