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

Atrial Septal Defect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00650936
• Other study ID #: AGA-014
• Status: Completed
• Phase: N/A
• Start date: August 2007
• Est. completion date: June 2014

Study information

• Verified date: June 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Atrial Septal Defect
• Heart Septal Defects
• Heart Septal Defects, Atrial

Intervention

Device:
• AMPLATZER Septal Occluder
AMPLATZER Septal Occluder

Locations

Country	Name	City	State
United States	Akron Children's Hospital	Akron	Ohio
United States	University of Michigan	Ann Arbor	Michigan
United States	Children's Healthcare of Atlanta	Atlanta	Georgia
United States	Aurora Denver Cardiology Associates	Aurora	Colorado
United States	North Austin Medical Center	Austin	Texas
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Sanger Heart & Vascular Institute/Carolinas Medical Center	Charlotte	North Carolina
United States	Universtiy of Virginia	Charlottesville	Virginia
United States	Rush University Medical Center	Chicago	Illinois
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	The Children's Hospital at Cleveland Clinic	Cleveland	Ohio
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	Driscoll Children's Hospital	Corpus Christi	Texas
United States	Children's Hospital of Michigan	Detroit	Michigan
United States	INOVA Fairfax Hospital	Falls Church	Virginia
United States	East Carolina University	Greenville	North Carolina
United States	Joe DiMaggio Children's Hospital	Hollywood	Florida
United States	Indiana University	Indianapolis	Indiana
United States	Riley Hospital for Children	Indianapolis	Indiana
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Jacksonville Pediatric Cardiovascular Center	Jacksonville	Florida
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	University of Kentucky	Lexington	Kentucky
United States	Kaiser Permanente	Los Angeles	California
United States	Medical Center of the Rockies	Loveland	Colorado
United States	Children's Hospital of Central California	Madera	California
United States	LeBonheur Children's Hospital	Memphis	Tennessee
United States	Miami Children's Hospital	Miami	Florida
United States	Aurora Health Care	Milwaukee	Wisconsin
United States	Children's Hospitals and Clinics of Minnesota	Minneapolis	Minnesota
United States	Vanderbilt University	Nashville	Tennessee
United States	Vanderbilt University-Children's	Nashville	Tennessee
United States	Schneider Children's Hospital	New Hyde Park	New York
United States	Children's Hospital of New Orleans	New Orleans	Louisiana
United States	Children's Hospital of New York-Presbyterian	New York	New York
United States	The New York Presbyterian Hospital - Cornell Campus	New York	New York
United States	Hope Children's Hospital	Oak Lawn	Illinois
United States	Children's Hospital Oakland	Oakland	California
United States	The Children's Hospital	Oklahoma City	Oklahoma
United States	Arnold Palmer Hospital for Children	Orlando	Florida
United States	Hahnemann University Hospital	Philadelphia	Pennsylvania
United States	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	Children's Hospital at Strong	Rochester	New York
United States	Washington University	Saint Louis	Missouri
United States	University of California, San Francisco	San Francisco	California
United States	Sacred Heart Children's Hospital	Spokane	Washington
United States	Tampa General Hospital	Tampa	Florida
United States	Children's National Medical Center	Washington	District of Columbia
United States	Washington Hospital Center	Washington	District of Columbia
United States	Moffitt Heart and Vascular Group	Wormleysburg	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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