Closure of Atrial Septal Defects With the AMPLATZER Septal Occluder - Post Approval Study
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ClinicalTrials.gov Identifier: NCT00650936 |
Recruitment Status
: Unknown
Verified January 2015 by St. Jude Medical.
Recruitment status was: Active, not recruiting
First Posted
: April 2, 2008
Last Update Posted
: February 3, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Atrial Septal Defect | Device: AMPLATZER Septal Occluder | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1000 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Study Start Date : | August 2007 |
Estimated Primary Completion Date : | June 2015 |
Estimated Study Completion Date : | June 2015 |
Arm | Intervention/treatment |
---|---|
Experimental: I |
Device: AMPLATZER Septal Occluder
AMPLATZER Septal Occluder
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- The primary objective is to evaluate the risk of hemodynamic compromise in patients who receive the AMPLATZER Septal Occluder device. [ Time Frame: 24 months ]
- The co-primary objective is to assess the safety and effectiveness of the AMPLATZER Septal Occluder device and delivery system. [ Time Frame: 24 months ]

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00650936

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | St. Jude Medical |
ClinicalTrials.gov Identifier: | NCT00650936 History of Changes |
Other Study ID Numbers: |
AGA-014 |
First Posted: | April 2, 2008 Key Record Dates |
Last Update Posted: | February 3, 2015 |
Last Verified: | January 2015 |
Keywords provided by St. Jude Medical:
Atrial Septal Defect |
Additional relevant MeSH terms:
Heart Septal Defects Heart Septal Defects, Atrial Heart Defects, Congenital Cardiovascular Abnormalities |
Cardiovascular Diseases Heart Diseases Congenital Abnormalities |