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

Purpose

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	Intervention
Atrial Septal Defect	Device: AMPLATZER Septal Occluder

Study Type:	Interventional
Study Design:	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 primary objective is to evaluate the risk of hemodynamic compromise in patients who receive the AMPLATZER Septal Occluder device. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The co-primary objective is to assess the safety and effectiveness of the AMPLATZER Septal Occluder device and delivery system. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1000
Study Start Date:	August 2007
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: I	Device: AMPLATZER Septal Occluder AMPLATZER Septal Occluder

Eligibility

Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00650936

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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
Washington Hospital Center
Washington, District of Columbia, United States, 20010
Children's National Medical Center
Washington, District of Columbia, United States, 20010-2970
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
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Indiana University
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

AGA Medical Corporation

More Information

No publications provided

Responsible Party:	AGA Medical Corporation
ClinicalTrials.gov Identifier:	NCT00650936 History of Changes
Other Study ID Numbers:	AGA-014
Study First Received:	March 31, 2008
Last Updated:	March 27, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by AGA Medical Corporation:

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

ClinicalTrials.gov processed this record on May 19, 2013