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

pfm medical

Status

Completed

Conditions

Heart Septal Defects, Ventricular

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00390702

pfm 01/2005

Details and patient eligibility

About

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.

Enrollment

103 patients

Sex

All

Ages

2+ years old

Volunteers

No Healthy Volunteers

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.