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

NCT00390702 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2018-11-07

No results posted yet for this study

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

DEVICE

transcatheter implantation of a VSD occluder (Nitinol coil)

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

Sponsors & Collaborators

  • Aix Scientifics

    collaborator INDUSTRY

  • pfm medical gmbh

    lead INDUSTRY

Principal Investigators

  • Thomas Meinertz, Prof Dr med · University Hospital Hamburg Eppendorf, Germany

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2012-08-31
Completion
2017-05-31

Countries

  • Germany
  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00390702 on ClinicalTrials.gov