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

Not Applicable

Completed

• Conditions: Atrial Septal Defect

• Registration Number: NCT00650936
• Lead Sponsor: Abbott Medical Devices

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2008-03-31
• Study First Submitted QC: 2008-03-31
• Study First Posted: 2008-04-02
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2019-06
• Results First Submitted: 2019-06-07
• Results First Submitted QC: 2019-06-07
• Results First Posted: 2019-06-25
• Last Update Submitted: 2019-06-25
• Last Update Posted: 2019-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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).

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percent of Subjects With Two-year Device-related Hemodynamic Compromise	24 months	The primary efficacy endpoint was the two-year incidence rate of device-related hemodynamic compromise.
Co-Primary Effectiveness Endpoint	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
Co-Primary Safety Endpoint	24 months	The co-primary safety endpoint was the percentage of subjects experiencing a device or delivery system related adverse event

Trial Locations

Locations (51)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

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, District of Columbia, United States

Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

Joe DiMaggio Children's Hospital; 🇺🇸 Hollywood, Florida, United States

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