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Closure of Atrial Septal Defects With the AMPLATZER Septal Occluder - Post Approval Study

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ClinicalTrials.gov Identifier: NCT00650936
Recruitment Status : Unknown
Verified January 2015 by St. Jude Medical.
Recruitment status was:  Active, not recruiting
First Posted : April 2, 2008
Last Update Posted : February 3, 2015
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical

Study Description
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Brief Summary:
The purpose of this study is to prospectively evaluate the incidence of hemodynamic compromise and to obtain long-term survival data on patients with the AMPLATZER Septal Occluder

Condition or disease Intervention/treatment Phase
Atrial Septal Defect Device: AMPLATZER Septal Occluder Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : August 2007
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : June 2015
Arms and Interventions
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Arm Intervention/treatment
Experimental: I Device: AMPLATZER Septal Occluder
AMPLATZER Septal Occluder


Outcome Measures
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Primary Outcome Measures :
  1. The primary objective is to evaluate the risk of hemodynamic compromise in patients who receive the AMPLATZER Septal Occluder device. [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. The co-primary objective is to assess the safety and effectiveness of the AMPLATZER Septal Occluder device and delivery system. [ Time Frame: 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must meet all inclusion criteria. A patient meets inclusion criteria if he/she:

    • is indicated for implantation with the AMPLATZER Septal Occluder for occlusion of a secundum atrial septal defect (Note: This does not include the indication for closure of a fenestration following a fenestrated Fontan procedure),
    • is willing and able to complete the follow-up requirements of this study, and
    • signs the informed consent (or a legal representative signs the informed consent).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00650936


  Show 51 Study Locations
Sponsors and Collaborators
St. Jude Medical
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00650936     History of Changes
Other Study ID Numbers: AGA-014
First Posted: April 2, 2008    Key Record Dates
Last Update Posted: February 3, 2015
Last Verified: January 2015

Keywords provided by St. Jude Medical:
Atrial
Septal
Defect

Additional relevant MeSH terms:
Heart Septal Defects
Heart Septal Defects, Atrial
Heart Defects, Congenital
Cardiovascular Abnormalities
 Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities