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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:
AGA Medical Corporation
ClinicalTrials.gov Identifier:
NCT00583596
First received: December 20, 2007
Last updated: January 31, 2010
Last verified: January 2010
History of Changes
  Purpose

The objective of the study is to determine safety, effectiveness and clinical utility of the AMPLATZER Duct Occluder in patients with patent ductus arteriosus.


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

AGA Medical Corporation has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

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

Further study details as provided by AGA Medical Corporation:

Primary Outcome Measures:
  • The rate of serious and major adverse events will be ≤ 6%. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The residual patency rate is expected to be < 15% by Doppler color flow mapping and <5% by clinical exam. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 441
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: 1 Device: Device closure with AMPLATZER Duct Occluder
Device closure with AMPLATZER Duct Occluder
2 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00583596

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

Additional Information:
FDA Approval Order  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Tammy Benson, AGA Medical Corporation
ClinicalTrials.gov Identifier: NCT00583596     History of Changes
Other Study ID Numbers: AGA-004, G980103
Study First Received: December 20, 2007
Last Updated: January 31, 2010
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
Heart Defects, Congenital
Cardiovascular Abnormalities
 Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on June 18, 2013