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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AGA Medical Corporation
ClinicalTrials.gov Identifier:
NCT00583596
First received: December 20, 2007
Last updated: July 17, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Patent Ductus Arteriosus (PDA)
Device: Device closure with AMPLATZER Duct Occluder
Other: Objective Performance Criteria

Access to an investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

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

Resource links provided by NLM:


Further study details as provided by AGA Medical Corporation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
    The number of participants with a residual shunt (efficacy)


Enrollment: 436
Study Start Date: October 1999
Study Completion Date: February 2009
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: implant to close PDA Device: Device closure with AMPLATZER Duct Occluder
Device closure with AMPLATZER Duct Occluder
Other: Objective Performance Criteria
Compare results of device closure to objective performance criteria

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT00583596

  Show 24 Study Locations
Sponsors and Collaborators
AGA Medical Corporation
  More Information

No publications provided

Responsible Party: AGA Medical Corporation
ClinicalTrials.gov Identifier: NCT00583596     History of Changes
Other Study ID Numbers: AGA-004, G980103
Study First Received: December 20, 2007
Results First Received: January 17, 2014
Last Updated: July 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AGA Medical Corporation:
patent ductus arteriosus (PDA)

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

ClinicalTrials.gov processed this record on November 27, 2014