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

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Patent ductus arteriosus
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Safety and Effectiveness Study With a New PDA Occluder for Closure of Patent Ductus Arteriosus

Brief Title

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

Brief Summary

      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.

Study Type

Interventional

Primary Outcome

Reporting of Late Adverse Events Relating to the Device.

Condition

Patent Ductus Arteriosus (PDA)

Intervention

Device closure with AMPLATZER Duct Occluder

Study Arms / Comparison Groups

 implant to close PDA
Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

436

Start Date

October 1999

Completion Date

February 2009

Primary Completion Date

April 2008

Eligibility Criteria

        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

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00583596

Organization ID

AGA-004

Secondary IDs

G980103

Responsible Party

Sponsor

Study Sponsor

Abbott Medical Devices

Study Sponsor

, ,

Verification Date

January 2019