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

Primary Purpose

Atrial Septal Defect

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AMPLATZER Septal Occluder
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Septal Defect focused on measuring Atrial, Septal, Defect

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University of Alabama at Birmingham
  • Kaiser Permanente
  • Children's Hospital of Central California
  • Children's Hospital Oakland
  • University of California, San Francisco
  • Aurora Denver Cardiology Associates
  • Medical Center of the Rockies
  • Children's National Medical Center
  • Washington Hospital Center
  • Joe DiMaggio Children's Hospital
  • Jacksonville Pediatric Cardiovascular Center
  • Miami Children's Hospital
  • Arnold Palmer Hospital for Children
  • Tampa General Hospital
  • Children's Healthcare of Atlanta
  • Rush University Medical Center
  • Hope Children's Hospital
  • Indiana University
  • Riley Hospital for Children
  • University of Kentucky
  • Children's Hospital of New Orleans
  • University of Michigan
  • Children's Hospital of Michigan
  • Children's Hospitals and Clinics of Minnesota
  • University of Mississippi Medical Center
  • Washington University
  • Dartmouth-Hitchcock Medical Center
  • Schneider Children's Hospital
  • The New York Presbyterian Hospital - Cornell Campus
  • Children's Hospital of New York-Presbyterian
  • Children's Hospital at Strong
  • Sanger Heart & Vascular Institute/Carolinas Medical Center
  • East Carolina University
  • Akron Children's Hospital
  • Cincinnati Children's Hospital Medical Center
  • The Children's Hospital at Cleveland Clinic
  • Nationwide Children's Hospital
  • The Children's Hospital
  • Hahnemann University Hospital
  • Children's Hospital of Pittsburgh
  • Moffitt Heart and Vascular Group
  • Medical University of South Carolina
  • LeBonheur Children's Hospital
  • Vanderbilt University-Children's
  • Vanderbilt University
  • North Austin Medical Center
  • Driscoll Children's Hospital
  • Universtiy of Virginia
  • INOVA Fairfax Hospital
  • Sacred Heart Children's Hospital
  • Aurora Health Care

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

AMPLATZER Septal Occluder

Arm Description

Subjects were enrolled if the implant of the AMPLATZER Septal Occluder device was completed or was attempted (delivery system entered the subject's body).

Outcomes

Primary Outcome Measures

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.
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
Co-Primary Safety Endpoint
The co-primary safety endpoint was the percentage of subjects experiencing a device or delivery system related adverse event

Secondary Outcome Measures

Full Information

First Posted
March 31, 2008
Last Updated
June 25, 2019
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT00650936
Brief Title
Closure of Atrial Septal Defects With the AMPLATZER Septal Occluder - Post Approval Study
Official Title
Closure of Atrial Septal Defects With the AMPLATZER Septal Occluder - Post Approval Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Septal Defect
Keywords
Atrial, Septal, Defect

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AMPLATZER Septal Occluder
Arm Type
Other
Arm Description
Subjects were enrolled if the implant of the AMPLATZER Septal Occluder device was completed or was attempted (delivery system entered the subject's body).
Intervention Type
Device
Intervention Name(s)
AMPLATZER Septal Occluder
Intervention Description
AMPLATZER Septal Occluder
Primary Outcome Measure Information:
Title
Percent of Subjects With Two-year Device-related Hemodynamic Compromise
Description
The primary efficacy endpoint was the two-year incidence rate of device-related hemodynamic compromise.
Time Frame
24 months
Title
Co-Primary Effectiveness Endpoint
Description
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
Time Frame
24 months
Title
Co-Primary Safety Endpoint
Description
The co-primary safety endpoint was the percentage of subjects experiencing a device or delivery system related adverse event
Time Frame
24 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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).
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Kaiser Permanente
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Children's Hospital of Central California
City
Madera
State/Province
California
ZIP/Postal Code
93636
Country
United States
Facility Name
Children's Hospital Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Aurora Denver Cardiology Associates
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Medical Center of the Rockies
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80538
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010-2970
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Joe DiMaggio Children's Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Jacksonville Pediatric Cardiovascular Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Miami Children's Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Arnold Palmer Hospital for Children
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Children's Healthcare of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30341
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Hope Children's Hospital
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Riley Hospital for Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Children's Hospital of New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70118
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Children's Hospital of Michigan
City
Detroit
State/Province
Michigan
ZIP/Postal Code
84201
Country
United States
Facility Name
Children's Hospitals and Clinics of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Schneider Children's Hospital
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
The New York Presbyterian Hospital - Cornell Campus
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Children's Hospital of New York-Presbyterian
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Children's Hospital at Strong
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Sanger Heart & Vascular Institute/Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Akron Children's Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
The Children's Hospital at Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
The Children's Hospital
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Hahnemann University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Moffitt Heart and Vascular Group
City
Wormleysburg
State/Province
Pennsylvania
ZIP/Postal Code
17043
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
LeBonheur Children's Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
Vanderbilt University-Children's
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
North Austin Medical Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
Driscoll Children's Hospital
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78412
Country
United States
Facility Name
Universtiy of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
INOVA Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Sacred Heart Children's Hospital
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Aurora Health Care
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28801537
Citation
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.
Results Reference
derived

Learn more about this trial

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

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