Closure of Atrial Septal Defects With the AMPLATZER Septal Occluder - Post Approval Study
This study is ongoing, but not recruiting participants.
Sponsor:
St. Jude Medical
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00650936
First received: March 31, 2008
Last updated: January 30, 2015
Last verified: January 2015
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Purpose
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
| Condition | Intervention |
|---|---|
|
Atrial Septal Defect |
Device: AMPLATZER Septal Occluder |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Further study details as provided by St. Jude Medical:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 1000 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: I |
Device: AMPLATZER Septal Occluder
AMPLATZER Septal Occluder
|
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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).
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00650936
Show 51 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00650936
Show 51 Study Locations
Sponsors and Collaborators
St. Jude Medical
More Information
| Responsible Party: | St. Jude Medical |
| ClinicalTrials.gov Identifier: | NCT00650936 History of Changes |
| Other Study ID Numbers: | AGA-014 |
| Study First Received: | March 31, 2008 |
| Last Updated: | January 30, 2015 |
| Health Authority: | United States: Institutional Review Board |
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 |
ClinicalTrials.gov processed this record on September 27, 2016