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

NCT01063712 | Completed Phase 2 Results DMC

• 2 other identifiers: PFM-P034Bioethics Committee
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease

Keywords

Ductus; Patent ductus Arterious; "Nit-Occlud® PDA-R"; Interventional closure of PDA; Percutaneous closure

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (1)

Nit-Occlud PDA-R

OTHER

Interventional, prospective clinical study, non randomized.

Device: Nit-Occlud® PDA-R

Interventions

Nit-Occlud® PDA-R 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.

Also known as: Device - Med - Nit Occlud PDA

Nit-Occlud PDA-R

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Infections that occur during acute bacteremia, viremia, which can be treated
• Febrile syndrome
• Tooth decay
• 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

Sponsors & Collaborators

• pfm S.R.L.: lead

Study Sites (1)

Kardiozentrum and Surgical Medical Center Boliviano Belga

La Paz, Murillo, 100, Bolivia

Location

Related Publications (3)

• 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.

  PMID: 19882712 BACKGROUND

• 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.

  PMID: 21805617 BACKGROUND

• 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.

  PMID: 21774843 RESULT

Related Links

• CSI Frankfurt 08´ - Closure of Very Large PDAs with New Device

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Limitations and Caveats

The number of participants is small, because the participants were recruited in high altitude cities over 2700m above the sea level. At this altitude bigger defects are more frequent to find than little ones, so is pulmonary hypertension.

Results Point of Contact

• Title: Alexandra Heath MD Ph.D
• Organization: Cardiology Medical Center "Kardiozentrum"

draheath@gmail.com

005912 2785037

Study Officials

• Alexandra Heath, MD, Ph.D

  Kardiozentrum

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2010
• First Posted: February 5, 2010
• Study Start: June 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: May 24, 2012
• Results First Posted: May 24, 2012

Record last verified: 2012-05

Locations

BO (1)