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

May 22, 2012 updated by: pfm S.R.L.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bolivia
    • Murillo
      • La Paz, Murillo, Bolivia, 100
        • Kardiozentrum and Surgical Medical Center Boliviano Belga

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 Names:
  • Device - Med - Nit Occlud PDA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to one year after percutaneous closure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

pfm S.R.L.

Investigators

  • Principal Investigator: Alexandra Heath, MD, Ph.D, Kardiozentrum

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

February 4, 2010

First Submitted That Met QC Criteria

February 4, 2010

First Posted (Estimate)

February 5, 2010

Study Record Updates

Last Update Posted (Estimate)

May 24, 2012

Last Update Submitted That Met QC Criteria

May 22, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PFM-P034
  • Bioethics Committee (Registry Identifier: 08-06-2009)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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