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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Congenital Heart Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nit-Occlud PDA-R

Interventional, prospective clinical study, non randomized.

Group Type OTHER

Nit-Occlud® PDA-R

Intervention Type DEVICE

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.

Interventions

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Nit-Occlud® PDA-R

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.

Intervention Type DEVICE

Other Intervention Names

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Device - Med - Nit Occlud PDA

Eligibility Criteria

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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

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

* 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

Eligible Sex

ALL

Accepts Healthy Volunteers

No