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

pfm medical

Status and phase: Completed; Phase 2

Conditions: Congenital Heart Disease

Treatments: Device: Nit-Occlud® PDA-R

Study type: Interventional

Funder types: Industry

Identifiers

NCT01063712

PFM-P034

Bioethics Committee (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

Nit-Occlud PDA-R

Other group

Description:

Interventional, prospective clinical study, non randomized.

Treatment:

Device: Nit-Occlud® PDA-R