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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AGA Medical Corporation
ClinicalTrials.gov Identifier:
NCT00650936
First received: March 31, 2008
Last updated: June 23, 2014
Last verified: June 2014

March 31, 2008
June 23, 2014
August 2007
December 2014   (final data collection date for primary outcome measure)
The primary objective is to evaluate the risk of hemodynamic compromise in patients who receive the AMPLATZER Septal Occluder device. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00650936 on ClinicalTrials.gov Archive Site
The co-primary objective is to assess the safety and effectiveness of the AMPLATZER Septal Occluder device and delivery system. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Closure of Atrial Septal Defects With the AMPLATZER Septal Occluder - Post Approval Study
Not Provided

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

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Atrial Septal Defect
Device: AMPLATZER Septal Occluder
AMPLATZER Septal Occluder
Experimental: I
Intervention: Device: AMPLATZER Septal Occluder
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1000
December 2014
December 2014   (final data collection date for primary outcome measure)

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).
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00650936
AGA-014
No
AGA Medical Corporation
AGA Medical Corporation
Not Provided
Not Provided
AGA Medical Corporation
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP