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. 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
Information provided by (Responsible Party):
St. Jude Medical

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 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

Arm Intervention/treatment
Experimental: I Device: AMPLATZER Septal Occluder
AMPLATZER Septal Occluder

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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier (NCT number): NCT00650936

  Hide Study Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Kaiser Permanente
Los Angeles, California, United States, 90027
Children's Hospital of Central California
Madera, California, United States, 93636
Children's Hospital Oakland
Oakland, California, United States, 94609
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Colorado
Aurora Denver Cardiology Associates
Aurora, Colorado, United States, 80012
Medical Center of the Rockies
Loveland, Colorado, United States, 80538
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010-2970
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Joe DiMaggio Children's Hospital
Hollywood, Florida, United States, 33021
Jacksonville Pediatric Cardiovascular Center
Jacksonville, Florida, United States, 32207
Miami Children's Hospital
Miami, Florida, United States, 33165
Arnold Palmer Hospital for Children
Orlando, Florida, United States, 32806
Tampa General Hospital
Tampa, Florida, United States, 33609
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30341
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Hope Children's Hospital
Oak Lawn, Illinois, United States, 60453
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
United States, Louisiana
Children's Hospital of New Orleans
New Orleans, Louisiana, United States, 70118
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Children's Hospital of Michigan
Detroit, Michigan, United States, 84201
United States, Minnesota
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, United States, 55404
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
Schneider Children's Hospital
New Hyde Park, New York, United States, 11040
The New York Presbyterian Hospital - Cornell Campus
New York, New York, United States, 10021
Children's Hospital of New York-Presbyterian
New York, New York, United States, 10032
Children's Hospital at Strong
Rochester, New York, United States, 14618
United States, North Carolina
Sanger Heart & Vascular Institute/Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
East Carolina University
Greenville, North Carolina, United States, 27834
United States, Ohio
Akron Children's Hospital
Akron, Ohio, United States, 44308
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
The Children's Hospital at Cleveland Clinic
Cleveland, Ohio, United States, 44195
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
United States, Oklahoma
The Children's Hospital
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Hahnemann University Hospital
Philadelphia, Pennsylvania, United States, 19102
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Moffitt Heart and Vascular Group
Wormleysburg, Pennsylvania, United States, 17043
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
LeBonheur Children's Hospital
Memphis, Tennessee, United States, 38105
Vanderbilt University-Children's
Nashville, Tennessee, United States, 37232
Vanderbilt University
Nashville, Tennessee, United States, 37232
United States, Texas
North Austin Medical Center
Austin, Texas, United States, 78758
Driscoll Children's Hospital
Corpus Christi, Texas, United States, 78412
United States, Virginia
Universtiy of Virginia
Charlottesville, Virginia, United States, 22908
INOVA Fairfax Hospital
Falls Church, Virginia, United States, 22042
United States, Washington
Sacred Heart Children's Hospital
Spokane, Washington, United States, 99204
United States, Wisconsin
Aurora Health Care
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
St. Jude Medical

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: St. Jude Medical 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:

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