Congenital Heart Disease Clinical Trial
Official title:
Safety and Effectiveness of the Device "Nit-Occlud® PDA-R" for Percutaneous Closure of Patent Arterial Duct Between 2 and 8 mm in Patients Treated Interventionally in Specialized Centers
The purpose of this study is to evaluate the safety and the effectiveness of the device "Nit-Occlud® PDA-R" in the percutaneous closure of patent ductus.
During the years 2003 to 2008, the Cardiological Medical Center "Kardiozentrum" evaluated
1136 patients with echocardiographic studies, 14.7% of the patients were diagnosed with
patent arterial duct. The PDA is an abnormal communication between the aorta and pulmonary
artery. Untreated it can rise the intrapulmonary pressure and lead to serious complications
like cardiac insufficiency.
The incidence of ducts as an isolated heart disease is between 3.6 and 7% of all congenital
heart diseases at sea level, and 10 - 14% at high altitude; rising up to 20% in cities at
more than 2.500 m about sea level. The ducts at high altitude are generally wider and larger
than at sea level.
One treatment alternative is a percutaneous transluminal implantation of a permanent implant
which closes the defect. The device under investigation "Nit-Occlud® PDA-R" is developed for
closure of the PDA with a minimal diameter of 2-8 mm.
The device performs the function of generating the defect occlusion by the body itself. The
implant stimulates the body to generate an epithelium over the implant so that the PDA
closes.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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