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

Launched by PFM S.R.L. · Feb 4, 2010

Keywords

ClinConnect Summary

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 s...

Gender

ALL

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