Closure of Atrial Septal Defects With the AMPLATZER Septal Occluder - Post Approval Study
1 other identifier
interventional
1,000
1 country
51
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2007
Longer than P75 for not_applicable
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 31, 2008
CompletedFirst Posted
Study publicly available on registry
April 2, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedResults Posted
Study results publicly available
June 25, 2019
CompletedJuly 9, 2019
June 1, 2019
6.8 years
March 31, 2008
June 7, 2019
June 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Percent of Subjects With Two-year Device-related Hemodynamic Compromise
The primary efficacy endpoint was the two-year incidence rate of device-related hemodynamic compromise.
24 months
Co-Primary Effectiveness Endpoint
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
24 months
Co-Primary Safety Endpoint
The co-primary safety endpoint was the percentage of subjects experiencing a device or delivery system related adverse event
24 months
Study Arms (1)
AMPLATZER Septal Occluder
OTHERSubjects were enrolled if the implant of the AMPLATZER Septal Occluder device was completed or was attempted (delivery system entered the subject's body).
Interventions
Eligibility Criteria
You may qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (51)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Kaiser Permanente
Los Angeles, California, 90027, United States
Children's Hospital of Central California
Madera, California, 93636, United States
Children's Hospital Oakland
Oakland, California, 94609, United States
University of California, San Francisco
San Francisco, California, 94143, United States
Aurora Denver Cardiology Associates
Aurora, Colorado, 80012, United States
Medical Center of the Rockies
Loveland, Colorado, 80538, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021, United States
Jacksonville Pediatric Cardiovascular Center
Jacksonville, Florida, 32207, United States
Miami Children's Hospital
Miami, Florida, 33165, United States
Arnold Palmer Hospital for Children
Orlando, Florida, 32806, United States
Tampa General Hospital
Tampa, Florida, 33609, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30341, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Hope Children's Hospital
Oak Lawn, Illinois, 60453, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Children's Hospital of New Orleans
New Orleans, Louisiana, 70118, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Children's Hospital of Michigan
Detroit, Michigan, 84201, United States
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, 55404, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Washington University
St Louis, Missouri, 63110, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Schneider Children's Hospital
New Hyde Park, New York, 11040, United States
The New York Presbyterian Hospital - Cornell Campus
New York, New York, 10021, United States
Children's Hospital of New York-Presbyterian
New York, New York, 10032, United States
Children's Hospital at Strong
Rochester, New York, 14618, United States
Sanger Heart & Vascular Institute/Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
East Carolina University
Greenville, North Carolina, 27834, United States
Akron Children's Hospital
Akron, Ohio, 44308, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
The Children's Hospital at Cleveland Clinic
Cleveland, Ohio, 44195, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
The Children's Hospital
Oklahoma City, Oklahoma, 73104, United States
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19102, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Moffitt Heart and Vascular Group
Wormleysburg, Pennsylvania, 17043, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
LeBonheur Children's Hospital
Memphis, Tennessee, 38105, United States
Vanderbilt University-Children's
Nashville, Tennessee, 37232, United States
Vanderbilt University
Nashville, Tennessee, 37232, United States
North Austin Medical Center
Austin, Texas, 78758, United States
Driscoll Children's Hospital
Corpus Christi, Texas, 78412, United States
Universtiy of Virginia
Charlottesville, Virginia, 22908, United States
INOVA Fairfax Hospital
Falls Church, Virginia, 22042, United States
Sacred Heart Children's Hospital
Spokane, Washington, 99204, United States
Aurora Health Care
Milwaukee, Wisconsin, 53215, United States
Related Publications (1)
Turner DR, Owada CY, Sang CJ Jr, Khan M, Lim DS. Closure of Secundum Atrial Septal Defects With the AMPLATZER Septal Occluder: A Prospective, Multicenter, Post-Approval Study. Circ Cardiovasc Interv. 2017 Aug;10(8):e004212. doi: 10.1161/CIRCINTERVENTIONS.116.004212.
PMID: 28801537DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Maren Wagner, Clinical Program Director
- Organization
- Abbott
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2008
First Posted
April 2, 2008
Study Start
August 1, 2007
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
July 9, 2019
Results First Posted
June 25, 2019
Record last verified: 2019-06