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

This study has suspended participant recruitment.
(further recruitment terminated after CE mark attained; enclosed patients will be followed up to 5 years)
Sponsor:
Collaborator:
Aix Scientifics
Information provided by (Responsible Party):
pfm medical ag
ClinicalTrials.gov Identifier:
NCT00390702
First received: October 19, 2006
Last updated: August 22, 2012
Last verified: August 2012
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by pfm medical ag:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • -- as a set of Performance Criteria is used, no additional sec. endpoints are defined. -- [ Time Frame: --- ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 338
Study Start Date: October 2006
Estimated Study Completion Date: August 2016
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00390702

Locations
Germany
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
Israel
Meyer Children's Hospital, Rambam Med. Center
Haifa, Israel, 31096
Sponsors and Collaborators
pfm medical ag
Aix Scientifics
Investigators
Principal Investigator: Thomas Meinertz, Prof Dr med University Hospital Hamburg Eppendorf, Germany
  More Information

No publications provided

Responsible Party: pfm medical ag
ClinicalTrials.gov Identifier: NCT00390702     History of Changes
Other Study ID Numbers: pfm 01/2005
Study First Received: October 19, 2006
Last Updated: August 22, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by pfm medical ag:
Ventricular septal defect
VSD

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

ClinicalTrials.gov processed this record on October 23, 2014