Safety and Effectiveness of the Device "Nit-Occlud® PDA-R"

Phase 2

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Clinical and echocardiographic compatibility with PDA without associated heart disease requiring surgical solution
Minimum diameter of the PDA 2 to 8 mm
Systolic pulmonary pressure measured during cardiac catheterization, not on pass 2/3 of the values of the systolic systemic pressure
Weight higher than 10 kg, regardless of age
Patients who were diagnosed and recruited during the period 2009 - 2010
Patients with trisomy 21 also fulfill the previous criteria, the number of patients with T21 will not exceed 10% of the entire group of patients.
letter of consent signed by parents or legal guardian

Relative

Exclusion Criteria

Exclusion Criteria:

Pregnant women
Pulmonary hypertension, increased to 2 / 3 of systemic pressure
Eisenmenger syndrome
Other associated heart disease, requiring surgical solution
Immuno-compromised patients
Pathology oncology
Hematologic or coagulation disorders
Allergy to contrast medium
Atypical or calcified Ductus
Parents or legal guardians who do not accept the risks of catheterization
Parents or legal guardians and patients who do not accept to sign the letter of consent or who revoke the consent.
Patients who participated in another clinical investigation during the last 3 months

Arm && Interventions

Group	Intervention	Description
Nit-Occlud PDA-R	Nit-Occlud® PDA-R	Interventional, prospective clinical study, non randomized.

Primary Outcome Measures

Name	Time	Method
Number of Patients With a Closed Patent Ductus Arteriosus (Defect) Determinated by Echocardiography ( Time Frame: One Year After Treatment)	up to one year after percutaneous closure	The closure rate is an effectiveness outcome. Complete closure without a residual shunt is defined as absence of color flow (an echocardiographic technique used to observe the flow of blood in the heart) between the aorta and the pulmonary artery through the duct. Additionally, the position of the device, regression of the dilation of the left ventricle and left atrium and assessing of unrestricted doppler flow in the descending aorta and left pulmonary artery were documented. Clinical status was also assessed.

Secondary Outcome Measures

Name	Time	Method
Number of Patients With a Decreased Dilation of the Left Heart Chamber (Time Frame: One Year After Treatment). Dilation of the Left Ventricle and Left Atrium Was Measured Before and One Year After Implantation by Echocardiography.	one year after percutaneous closure	The patients were examined clinically and echocardiographically after 24 hours, one month, three months and six months after the percutaneous closure. Dilation of the left ventricle and left atrium are consequences of the hyperflow through the ducts. Regression of both ventricle and atrium are expected after closure of the ducts and can be documented by echocardiography. Additionally, the position of the device and the doppler flow in the descending aorta and left pulmonary artery were documented.