Safety and Effectiveness of the Nit-Occlud® Lê VSD Spiral Coil System (pfm-01/2005)

November 5, 2018 updated by: pfm medical ag

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • Dept. Congem.Heart Defects, Deutsches Herzzentrum
      • Frankfurt, Germany, 60389
        • Cardio-Vascular Centre, Sankt Kathrinen
      • Giessen, Germany, 35390
        • Univ.Klinikum, Zentrum fuer Kinderheilkunde
      • Hamburg, Germany, 20246
        • Dept. Paediatric Cardiology, Univ. Hospital Hamburg
      • Munich, Germany, 81377
        • Dept. Paediatric Cardiology, Univ. Clinic Grosshadern
  • Israel
      • Haifa, Israel, 31096
        • Meyer Children's Hospital, Rambam Med. Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • VSD must be diagnosed by acknowledged methods, like echocardiography
  • Signs of left ventricular volume overload are present (left ventricle or left atrium diameters 2 standard deviations greater than normal) and/or measured by catheterisation : Qp/Qs > 1.5
  • Pulmonary vascular resistance is less than 4 Wood units
  • The patient is older than 24 months
  • The VSD has a perimembranous or muscular location.
  • A distance between the rim of the VSD and the aortic annulus of at least 3.0 mm (as measured on the 2-D echocardiography - apical 5-chamber view)
  • The minimal diameter (size) of the VSD is less than 8.0 mm (as measured on the 2-D echocardiography - apical 5-chamber view)
  • Patient must agree to fully participate in the clinical trial and give informed consent in writing. If the patient is without legal ability additionally the person of legal responsibility must agree and s/he must give the informed consent in writing

Exclusion Criteria:

Pathological or physical condition precluding the implantation of a Nit-Occlud® Lê VSD coil, such as :

  • perimembranous VSD with no evidence of circular aneurysm formation
  • Associated cardiac anomalies requiring surgery (greater than mild aortic insufficiency; such as aortic valve prolapse)
  • Active endocarditis or other type of sepsis or other active infection at time of implantation
  • Thrombus at or near the intended site of implantation
  • Thrombus in the vessels through which access to the VSD is gained (unless the patient is protected with an embolic protection device such as a vena cava filter)
  • Vessels through which access to the VSD is gained can not accommodate a 7 F sheath
  • Potential steric (3-dimensional) interference of the occluder with intracardiac or intravascular structures (like valves)
  • History of blood disorder (coagulopathy, tendency towards haemolysis)
  • History of hypersensitivity to contrast medium or Nitinol
  • AV-block II° or III°, atrial fibrillation, or atrial flutter
  • End stage cardiac disease, irreversible major organ failure, or terminal cancer
  • HIV infection
  • Cerebrovascular disease or neurological deterioration
  • Emergency cardiologic intervention
  • Patient*) is not able to fully participate in this study including all follow-ups (e.g. for mental or geographical reasons, or patient is intravenous drug user or has strong potential for non-compliance to medical regimes)
  • Patient, respectively the person of legal responsibility, is mentally unable to understand the nature, aims, or possible consequences of the clinical investigation
  • Pregnant or breast-feeding women
  • Patient did participate in another clinical investigation during the last 3 months
  • Patient or the person of responsibility has revoked the consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: VSD occluder
transcatheter implantation of a VSD occluder (Nitinol coil)
Device: transcatheter implantation of a VSD occluder (Nitinol coil)
transcatheter implantation, by first performing a arterial-venous loop through the defect
Other Names:
  • Nit-Occlud® Lê VSD Occluder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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: Five years
Five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

pfm medical ag

Collaborators

Aix Scientifics

Investigators

  • Principal Investigator: Thomas Meinertz, Prof Dr med, University Hospital Hamburg Eppendorf, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2006

Primary Completion (ACTUAL)

August 1, 2012

Study Completion (ACTUAL)

May 1, 2017

Study Registration Dates

First Submitted

October 19, 2006

First Submitted That Met QC Criteria

October 19, 2006

First Posted (ESTIMATE)

October 20, 2006

Study Record Updates

Last Update Posted (ACTUAL)

November 7, 2018

Last Update Submitted That Met QC Criteria

November 5, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pfm 01/2005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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