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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
pfm S.R.L.
ClinicalTrials.gov Identifier:
NCT01063712
First received: February 4, 2010
Last updated: May 22, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Congenital Heart Disease
Device: Nit-Occlud® PDA-R
Phase 2

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

Resource links provided by NLM:


Further study details as provided by pfm S.R.L.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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. [ Time Frame: one year after percutaneous closure ] [ Designated as safety issue: No ]
    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.


Enrollment: 29
Study Start Date: June 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Nit-Occlud PDA-R
Interventional, prospective clinical study, non randomized.
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.

Other Name: Device - Med - Nit Occlud PDA

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01063712

Locations
Bolivia
Kardiozentrum and Surgical Medical Center Boliviano Belga
La Paz, Murillo, Bolivia, 100
Sponsors and Collaborators
pfm S.R.L.
Investigators
Principal Investigator: Alexandra Heath, MD, Ph.D Kardiozentrum
  More Information

Additional Information:
Publications:
Responsible Party: pfm S.R.L.
ClinicalTrials.gov Identifier: NCT01063712     History of Changes
Other Study ID Numbers: PFM-P034, Bioethics Committee
Study First Received: February 4, 2010
Results First Received: February 23, 2011
Last Updated: May 22, 2012
Health Authority: Bolivia: Ethics Committee

Keywords provided by pfm S.R.L.:
Ductus
Patent ductus Arterious
"Nit-Occlud® PDA-R"
Interventional closure of PDA
Percutaneous closure

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on September 18, 2014