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

June 25, 2019 updated by: Abbott Medical Devices
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 months
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
24 months
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
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

March 31, 2008

First Submitted That Met QC Criteria

March 31, 2008

First Posted (Estimate)

April 2, 2008

Study Record Updates

Last Update Posted (Actual)

July 9, 2019

Last Update Submitted That Met QC Criteria

June 25, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGA-014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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