Emergency/Compassionate Use PFO Occluder
Primary Purpose
Patent Foramen Ovale, PFO
Status
Approved for marketing
Phase
Locations
Study Type
Expanded Access
Intervention
Device closure with the AMPLATZER PFO Occluder
Sponsored by
About this trial
This is an expanded access trial for Patent Foramen Ovale focused on measuring patent, foramen, ovale, PFO
Eligibility Criteria
Inclusion Criteria:
- Emergency/compassionate use for patients not meeting the inclusion criteria for the AMPLATZER PFO Access Registry.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00584064
First Posted
December 20, 2007
Last Updated
April 9, 2019
Sponsor
Abbott Medical Devices
1. Study Identification
Unique Protocol Identification Number
NCT00584064
Brief Title
Emergency/Compassionate Use PFO Occluder
Study Type
Expanded Access
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Approved for marketing
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
4. Oversight
5. Study Description
Brief Summary
Emergency/compassionate use for the AMPLATZER PFO Occluder
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patent Foramen Ovale, PFO
Keywords
patent, foramen, ovale, PFO
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Device closure with the AMPLATZER PFO Occluder
Intervention Description
Device closure with the AMPLATZER PFO Occluder
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Eligibility Criteria
Inclusion Criteria:
Emergency/compassionate use for patients not meeting the inclusion criteria for the AMPLATZER PFO Access Registry.
12. IPD Sharing Statement
Learn more about this trial
Emergency/Compassionate Use PFO Occluder
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