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

Completed · Not applicable

Conditions studied: Atrial Septal Defect

In brief

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

Key facts

Study ID

NCT00650936

Run by

Abbott Medical Devices

People needed

1000

Starts

2007-08-01

Expected to finish

2014-06-01

Last updated by the study team

2019-07-09

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

Where it is running

• 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
• University of California, San Francisco — San Francisco, California, United States
• Aurora Denver Cardiology Associates — Aurora, Colorado, United States
• Medical Center of the Rockies — Loveland, Colorado, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Joe DiMaggio Children's Hospital — Hollywood, Florida, United States
• Jacksonville Pediatric Cardiovascular Center — Jacksonville, Florida, United States
• Miami Children's Hospital — Miami, Florida, United States
• Arnold Palmer Hospital for Children — Orlando, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Hope Children's Hospital — Oak Lawn, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• University of Kentucky — Lexington, Kentucky, United States
• Children's Hospital of New Orleans — New Orleans, Louisiana, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Children's Hospital of Michigan — Detroit, Michigan, United States
• Children's Hospitals and Clinics of Minnesota — Minneapolis, Minnesota, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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