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OpenTrials
Completed

NCT Number: NCT00583596

Closure Of Patent Ductus Arteriosus With the AMPLATZER Duct Occluder the AMPLATZER® Duct Occluder

AGA-004 - The objective of the study is to determine safety, effectiveness and clinical utility of the AMPLATZER Duct Occluder in patients with patent ductus arteriosus. AGA-007 - The objective of this study is to evaluate the long term safety and effectiveness issues that may not have have been adequately addressed during AGA-004.

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Key information

Conditions

Patent Ductus Arteriosus (PDA) Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Ductus Arteriosus, Patent Heart Defects, Congenital Heart Diseases

Age range

6 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with a demonstrated patent ductus arteriosus
  • Body weight > 5 Kilograms

Exclusion criteria

  • Pulmonary vascular resistance above 8 Woods units or a Rp/Rs >0.4.
  • Additional cardiac or non-cardiac abnormality that can reasonably be expected to significantly affect the patient's health adversely in the next two years, i.e.: cancer, Eisenmenger's syndrome, other serious congenital heart disease.
  • Pelvic vein or inferior vena cava thrombosis
  • Sepsis (local/generalized) or any type of infection that cannot be successfully treated prior to device placement.
  • History of repeated pulmonary infection
  • Demonstrated intracardiac thrombi on echocardiography • Inability to obtain informed consent

Treatment and study plan

Device closure with AMPLATZER Duct Occluder

Device

Device closure with AMPLATZER Duct Occluder

Objective Performance Criteria

Other

Compare results of device closure to objective performance criteria

Primary outcomes

  1. Reporting of Late Adverse Events Relating to the Device.

    Time frame: Long term follow up for data captured at 5, 6 or 7 years post implant

  2. Reporting of Late Efficacy Issues Regarding Patent Ductus Arteriosis (PDA) Closure

    Time frame: Long term follow up data captured at 5, 6 or 7 years post implant

    The number of participants with a residual shunt (efficacy)

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Important dates

Study start
1999
Primary completion
2008
Study completion
2009
First posted
Dec 31, 2007
Registry last updated
Jun 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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