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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00650936
Recruitment Status : Completed
First Posted : April 2, 2008
Results First Posted : June 25, 2019
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Closure of Atrial Septal Defects With the AMPLATZER Septal Occluder - Post Approval Study
Study Start Date : August 2007
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Arm Intervention/treatment
AMPLATZER Septal Occluder
Subjects were enrolled if the implant of the AMPLATZER Septal Occluder device was completed or was attempted (delivery system entered the subject's body).
Device: AMPLATZER Septal Occluder
AMPLATZER Septal Occluder




Primary Outcome Measures :
  1. Percent of Subjects With Two-year Device-related Hemodynamic Compromise [ Time Frame: 24 months ]
    The primary efficacy endpoint was the two-year incidence rate of device-related hemodynamic compromise.

  2. Co-Primary Effectiveness Endpoint [ Time Frame: 24 months ]

    The percentage of subjects for whom closure success is achieved through two-years. To meet this endpoint, two criteria must be met:

    Technical Success: Successful deployment of the device percutaneously Closure Success: Closure of the atrial septal defect (i.e., a shunt < 2mm) without the need for surgical repair


  3. Co-Primary Safety Endpoint [ Time Frame: 24 months ]
    The co-primary safety endpoint was the percentage of subjects experiencing a device or delivery system related adverse event



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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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).

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


Locations
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Sponsors and Collaborators
Abbott Medical Devices
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT00650936    
Other Study ID Numbers: AGA-014
First Posted: April 2, 2008    Key Record Dates
Results First Posted: June 25, 2019
Last Update Posted: July 9, 2019
Last Verified: June 2019
Keywords provided by Abbott Medical Devices:
Atrial
Septal
Defect
Additional relevant MeSH terms:
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Heart Septal Defects
Heart Septal Defects, Atrial
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities