Safety and Effectiveness of the Device "Nit-Occlud® PDA-R"
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Intervention: Nit-Occlud® PDA-R
Intervention description: Transcatheter implantation of a PDA Device (Nitinol) The catheterism was done under sedation, using a protocol established by inserting a catheter through a femoral artery and/or vein directed to the heart and great vessels. Invasive measurements are obtained in the descending aorta and pulmonary artery. Once in ductal position, we inject iodinated contrast medium that allows us to observe via X-ray the ductal morphology; obtaining accurate measurements to choose the appropriate device. The device is then inserted via the catheter, closing the ductus.
The catheterism provides measures of aortic and pulmonary pressure, before, during and after the closure.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Healthy volunteers: No
Keywords: Ductus; Patent ductus Arterious; "Nit-Occlud® PDA-R"; Interventional closure of PDA; Percutaneous closure

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.
    

Eligibility criteria:

        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:

          -  Infections that occur during acute bacteremia, viremia, which can be treated

          -  Febrile syndrome

          -  Tooth decay

          -  Once the acute solved considering the patient's inclusion into the study

        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