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

Congenital Heart Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01063712
• Other study ID #: PFM-P034
• Secondary ID: Bioethics Commit
• Status: Completed
• Phase: Phase 2
• First received: February 4, 2010
• Last updated: May 22, 2012
• Start date: June 2009
• Est. completion date: December 2010

Study information

• Verified date: May 2012
• Source: pfm S.R.L.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bolivia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Bolivia	Kardiozentrum and Surgical Medical Center Boliviano Belga	La Paz	Murillo

Sponsors (1)

Lead Sponsor	Collaborator
pfm S.R.L.

Country where clinical trial is conducted

Bolivia, 

References & Publications (3)

Freudenthal FP, Heath A, Villanueva J, Mendes J, Vicente X, von Alvensleben I, Echazú 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):12 — View Citation

Heath A, Lang N, Levi DS, Granja M, Villanueva J, Navarro J, Echazú 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With a Closed Patent Ductus Arteriosus (Defect) Determinated by Echocardiography ( Time Frame: One Year After Treatment)	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.	up to one year after percutaneous closure	No
Secondary	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.	The patients were examined clinically and echocardiographically after 24 hours, one month, three months and six months after the percutaneous closure. Dilation of the left ventricle and left atrium are consequences of the hyperflow through the ducts. Regression of both ventricle and atrium are expected after closure of the ducts and can be documented by echocardiography. Additionally, the position of the device and the doppler flow in the descending aorta and left pulmonary artery were documented.	one year after percutaneous closure	No

External Links

•   40.Jahrestagung der Deutschen Gesellschaft für Pädiatrische Kardiologie Eingeladener Gast 2008 Society Italian di Cardiology Pediatric - Interventioneller Verschluss von Ductus arterious mit one new Device: Klinische Series auf 3600 m Höhe
•   CSI Frankfurt 08´ - Closure of Very Large PDAs with New Device