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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00390702
Recruitment Status : Suspended (further recruitment terminated after CE mark attained; enclosed patients will be followed up to 5 years)
First Posted : October 20, 2006
Last Update Posted : August 23, 2012
Aix Scientifics
Information provided by (Responsible Party):
pfm medical ag

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.

Condition or disease Intervention/treatment Phase
Heart Septal Defects, Ventricular Device: transcatheter implantation of a VSD occluder (Nitinol coil) Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 338 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 2006
Actual Primary Completion Date : August 2012
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

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 Name: Nit-Occlud® Lê VSD Occluder

Primary Outcome Measures :
  1. 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00390702

Dept. Congem.Heart Defects, Deutsches Herzzentrum
Berlin, Germany, 13353
Cardio-Vascular Centre, Sankt Kathrinen
Frankfurt, Germany, 60389
Univ.Klinikum, Zentrum fuer Kinderheilkunde
Giessen, Germany, 35390
Dept. Paediatric Cardiology, Univ. Hospital Hamburg
Hamburg, Germany, 20246
Dept. Paediatric Cardiology, Univ. Clinic Grosshadern
Munich, Germany, 81377
Meyer Children's Hospital, Rambam Med. Center
Haifa, Israel, 31096
Sponsors and Collaborators
pfm medical ag
Aix Scientifics
Principal Investigator: Thomas Meinertz, Prof Dr med University Hospital Hamburg Eppendorf, Germany

Responsible Party: pfm medical ag Identifier: NCT00390702     History of Changes
Other Study ID Numbers: pfm 01/2005
First Posted: October 20, 2006    Key Record Dates
Last Update Posted: August 23, 2012
Last Verified: August 2012

Keywords provided by pfm medical ag:
Ventricular septal defect

Additional relevant MeSH terms:
Heart Septal Defects
Heart Septal Defects, Ventricular
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities