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

NCT01063712 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2012-05-24

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • pfm S.R.L.

    lead INDUSTRY

Principal Investigators

  • Alexandra Heath, MD, Ph.D · Kardiozentrum

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • Bolivia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01063712 on ClinicalTrials.gov