Safety and Effectiveness of the Device "Nit-Occlud® PDA-R" for Percutaneous Closure of Patent Arterial Duct Between 2 and 8 mm in Patients Treated Interventionally in Specialized Centers
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 29
- Locations
- 2
- Primary Endpoint
- Number of Patients With a Closed Patent Ductus Arteriosus (Defect) Determinated by Echocardiography ( Time Frame: One Year After Treatment)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Outcomes
Primary Outcomes
Number of Patients With a Closed Patent Ductus Arteriosus (Defect) Determinated by Echocardiography ( Time Frame: One Year After Treatment)
Time Frame: 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 Outcomes
- 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)