Closure of Atrial Septal Defects With the AMPLATZER Septal Occluder - Post Approval Study
- Conditions
- Atrial Septal Defect
- Interventions
- Device: AMPLATZER Septal Occluder
- Registration Number
- NCT00650936
- Lead Sponsor
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1000
-
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).
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AMPLATZER Septal Occluder 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).
- Primary Outcome Measures
Name Time Method Percent of Subjects With Two-year Device-related Hemodynamic Compromise 24 months The primary efficacy endpoint was the two-year incidence rate of device-related hemodynamic compromise.
Co-Primary Effectiveness Endpoint 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 repairCo-Primary Safety Endpoint 24 months The co-primary safety endpoint was the percentage of subjects experiencing a device or delivery system related adverse event
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (51)
Jacksonville Pediatric Cardiovascular Center
🇺🇸Jacksonville, Florida, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Children's Hospital of New Orleans
🇺🇸New Orleans, Louisiana, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
East Carolina University
🇺🇸Greenville, North Carolina, United States
Hahnemann University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Children's Hospitals and Clinics of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Miami Children's Hospital
🇺🇸Miami, Florida, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Riley Hospital for Children
🇺🇸Indianapolis, Indiana, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Kaiser Permanente
🇺🇸Los Angeles, California, United States
Children's Hospital of Central California
🇺🇸Madera, California, United States
Children's Hospital Oakland
🇺🇸Oakland, California, United States
Joe DiMaggio Children's Hospital
🇺🇸Hollywood, Florida, United States
Hope Children's Hospital
🇺🇸Oak Lawn, Illinois, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Schneider Children's Hospital
🇺🇸New Hyde Park, New York, United States
The New York Presbyterian Hospital - Cornell Campus
🇺🇸New York, New York, United States
Children's Hospital of New York-Presbyterian
🇺🇸New York, New York, United States
Children's Hospital at Strong
🇺🇸Rochester, New York, United States
LeBonheur Children's Hospital
🇺🇸Memphis, Tennessee, United States
Sacred Heart Children's Hospital
🇺🇸Spokane, Washington, United States
Children's Healthcare of Atlanta
🇺🇸Atlanta, Georgia, United States
Akron Children's Hospital
🇺🇸Akron, Ohio, United States
Sanger Heart & Vascular Institute/Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
The Children's Hospital at Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
North Austin Medical Center
🇺🇸Austin, Texas, United States
Driscoll Children's Hospital
🇺🇸Corpus Christi, Texas, United States
Universtiy of Virginia
🇺🇸Charlottesville, Virginia, United States
Moffitt Heart and Vascular Group
🇺🇸Wormleysburg, Pennsylvania, United States
INOVA Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
Medical Center of the Rockies
🇺🇸Loveland, Colorado, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Aurora Denver Cardiology Associates
🇺🇸Aurora, Colorado, United States
Arnold Palmer Hospital for Children
🇺🇸Orlando, Florida, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Children's Hospital of Michigan
🇺🇸Detroit, Michigan, United States
The Children's Hospital
🇺🇸Oklahoma City, Oklahoma, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Vanderbilt University-Children's
🇺🇸Nashville, Tennessee, United States
Aurora Health Care
🇺🇸Milwaukee, Wisconsin, United States