AMPLATZER PFO Occluder Post Approval Study (PFO PAS)
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ClinicalTrials.gov Identifier: NCT03309332 |
Recruitment Status :
Recruiting
First Posted : October 13, 2017
Last Update Posted : January 31, 2023
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Tracking Information | |||||||
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First Submitted Date ICMJE | October 10, 2017 | ||||||
First Posted Date ICMJE | October 13, 2017 | ||||||
Last Update Posted Date | January 31, 2023 | ||||||
Actual Study Start Date ICMJE | January 31, 2018 | ||||||
Estimated Primary Completion Date | October 31, 2024 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | AMPLATZER PFO Occluder Post Approval Study | ||||||
Official Title ICMJE | OSB Lead-AMPLATZER PFO Occluder New Enrollment PAS | ||||||
Brief Summary | The purpose of this single arm, multi-center study is to confirm the safety and effectiveness of the AMPLATZER™ PFO Occluder in the post Approval Setting. | ||||||
Detailed Description | A maximum of 1214 adult subjects will be enrolled at up to 100 centers in the U.S. and Canada. Subjects will have follow-up at 1 month, 6 months, 12 months and annually thereafter through 5 years post implant. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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Condition ICMJE |
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Intervention ICMJE | Device: AMPLATZER™ PFO Occluder
Implantation of the AMPLATZER™ PFO Occluder in the PFO
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Study Arms ICMJE | Experimental: Device
Subjects implanted with the AMPLATZER™ PFO Occluder.
Intervention: Device: AMPLATZER™ PFO Occluder
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
1214 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | April 30, 2030 | ||||||
Estimated Primary Completion Date | October 31, 2024 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria: • Subjects with a PFO who have had an ischemic stroke within the last 547 days Exclusion Criteria:
Liver failure: Liver enzymes outside the normal reference range for the laboratory at the investigational site: poor liver function as assessed by elevated PT (above the normal reference range for the laboratory at the investigational site) and low total protein and albumin (below the normal reference range for the laboratory at the investigational site). Lung failure: Respiratory failure is retention of carbon dioxide more than 60 mmHg, poor oxygenation with oxygen tension less than 40 mmHg in room air or the need for assisted ventilation.
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 60 Years (Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Canada, Portugal, United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03309332 | ||||||
Other Study ID Numbers ICMJE | SJM-CIP-10187 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||
Current Responsible Party | Abbott Medical Devices | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | Abbott Medical Devices | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Abbott Medical Devices | ||||||
Verification Date | January 2023 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |