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

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.