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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2015 by St. Jude Medical.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00650936
First Posted: April 2, 2008
Last Update Posted: February 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
St. Jude Medical
March 31, 2008
April 2, 2008
February 3, 2015
August 2007
June 2015   (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 ]
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 ]
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
Intervention Model: Single Group Assignment
Masking: None (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.
 
Unknown status
1000
June 2015
June 2015   (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).
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00650936
AGA-014
No
Not Provided
Not Provided
St. Jude Medical
St. Jude Medical
Not Provided
Not Provided
St. Jude Medical
January 2015

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