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

NCT00390702 | Completed DMC

• 1 other identifier: pfm 01/2005
• Study Type: interventional
• Target: 103
• Locations: 2 countries
• Sites: 6

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.

Conditions

Heart Septal Defects, Ventricular

Keywords

Ventricular septal defect; VSD

Outcome Measures

Primary Outcomes (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

  Five years

Study Arms (1)

VSD occluder

EXPERIMENTAL

transcatheter implantation of a VSD occluder (Nitinol coil)

Device: transcatheter implantation of a VSD occluder (Nitinol coil)

Interventions

transcatheter implantation of a VSD occluder (Nitinol coil) DEVICE

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

Also known as: Nit-Occlud® Lê VSD Occluder

VSD occluder

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• pfm medical gmbh: lead
• Aix Scientifics: collaborator

Study Sites (6)

Dept. Congem.Heart Defects, Deutsches Herzzentrum

Berlin, 13353, Germany

Location

Cardio-Vascular Centre, Sankt Kathrinen

Frankfurt, 60389, Germany

Location

Univ.Klinikum, Zentrum fuer Kinderheilkunde

Giessen, 35390, Germany

Location

Dept. Paediatric Cardiology, Univ. Hospital Hamburg

Hamburg, 20246, Germany

Location

Dept. Paediatric Cardiology, Univ. Clinic Grosshadern

Munich, 81377, Germany

Location

Meyer Children's Hospital, Rambam Med. Center

Haifa, 31096, Israel

Location

MeSH Terms

Conditions

Heart Septal Defects, Ventricular

Condition Hierarchy (Ancestors)

Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Thomas Meinertz, Prof Dr med

  University Hospital Hamburg Eppendorf, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2006
• First Posted: October 20, 2006
• Study Start: October 1, 2006
• Primary Completion: August 1, 2012
• Study Completion: May 1, 2017
• Last Updated: November 7, 2018

Record last verified: 2018-11

Locations

IL (1); DE (5)