Clinical trial NCT01063712: Safety and Effectiveness of the Device "Nit-Occlud® PDA-R"
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Congenital Heart Disease
Keywords: Ductus
Patent ductus Arterious
"Nit-Occlud® PDA-R"
Interventional closure of PDA
Percutaneous closure
Lead sponsor: pfm S.R.L.
Sponsor class: INDUSTRY
First posted: 2010-02-05
Enrollment: 29
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Patients With a Closed Patent Ductus Arteriosus (Defect) Determinated by Echocardiography ( Time Frame: One Year After Treatment)
timeFrame: up to one year after percutaneous closure
Secondary outcomes:
measure: 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.
timeFrame: one year after percutaneous closure
Other outcomes:
Locations:
city: La Paz
country: Bolivia
facility: Kardiozentrum and Surgical Medical Center Boliviano Belga
state: Murillo
Study officials:
affiliation: Kardiozentrum
name: Alexandra Heath, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lang N, Schmitz C, Lehner A, Fuchs F, Heath A, Freudenthal F, Wintersperger BJ, Huber AM, Thein E, Netz H, Kozlik-Feldmann R. Preclinical evaluation of a new self-expanding device for closure of muscular ventricular septal defects in a pig model. Catheter Cardiovasc Interv. 2010 Feb 15;75(3):408-15. doi: 10.1002/ccd.22285.
citation: Heath A, Lang N, Levi DS, Granja M, Villanueva J, Navarro J, Echazu G, Kozlik-Feldmann R, del Nido P, Freudenthal F. Transcatheter closure of large patent ductus arteriosus at high altitude with a novel nitinol device. Catheter Cardiovasc Interv. 2012 Feb 15;79(3):399-407. doi: 10.1002/ccd.23302. Epub 2011 Dec 12.
citation: Freudenthal FP, Heath A, Villanueva J, Mendes J, Vicente X, von Alvensleben I, Echazu G, Navarro J, Lang N, Kozlik-Feldmann R. Chronic hypobaric hypoxia, patent arterial duct and a new interventional technique to close it. Cardiol Young. 2012 Apr;22(2):128-35. doi: 10.1017/S1047951111000990. Epub 2011 Jul 21.