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AMPLATZER PFO Occluder Post Approval Study

Study acronym: PFO PAS
StatusActive, Not Recruiting
PhaseNot applicable
Started2018-01-31
View on ClinicalTrials.gov ↗

Amendment history

2026-03-09
Study Status v33
Re-verified, no change to tracked fields
2025-11-12
Study Status, Contacts/Locations v32
Study sites89→88
2025-03-17
Study Status, Contacts/Locations v31
Study sitesdetails revised at 2 of 89 sites
2024-11-15
Recruiting→Active, Not Recruiting Study Status, Study Design, Eligibility, Contacts/Locations v30
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2024-10-31→2030-02-05
Completion date2030-04-30→2030-02-05
Study sites97→89
Eligibility criteria+1 characters
[...] r untreated infections Organ failure (kidney, liver or lung). Kidney failure: Poor urine output of less than 1 cc/kg/hr wi [...]
2024-04-08
Study Status, Contacts/Locations v29
Study sitesdetails revised at 2 of 97 sites
Show 28 earlier versions
2024-03-15
Study Status, Contacts/Locations v28
Study sitesdetails revised at 2 of 97 sites
2023-10-19
Study Status, Contacts/Locations v27
Study sitesdetails revised at 2 of 97 sites
2023-09-08
Study Status, Contacts/Locations v26
Study sites96→97
2023-08-02
Study Status, Contacts/Locations v25
Study sitesdetails revised at 2 of 96 sites
2023-07-07
Study Status, Contacts/Locations v24
Study sitesdetails revised at 3 of 96 sites
2023-06-25
Study Status, Contacts/Locations v23
Study sitesdetails revised at 1 of 96 sites
2023-06-06
Study Status, Contacts/Locations v22
Study sitesdetails revised at 3 of 96 sites
2023-05-15
Study Status, Contacts/Locations v21
Study sites95→96
2023-02-22
Study Status, Contacts/Locations v20
Study sites94→95
2023-02-03
Study Status, Contacts/Locations v19
Study sites91→94
2023-01-30
Study Status, Contacts/Locations v18
Study sites90→91
2022-12-19
Study Status, Contacts/Locations v17
Study sitesdetails revised at 10 of 90 sites
2022-08-09
Study Status, Contacts/Locations v16
Study sites89→90
2022-07-13
Study Status v15
Primary completion date2027-12→2024-10-31
Completion date2027-12→2030-04-30
Start date2018-01-04→2018-01-31
2022-06-16
Study Status, Contacts/Locations v14
Study sitesdetails revised at 1 of 89 sites
2022-04-04
Study Status, Contacts/Locations v13
Study sitesdetails revised at 2 of 89 sites
2022-02-25
Study Status, Contacts/Locations v12
Study sitesdetails revised at 1 of 89 sites
2022-02-11
Study Status v11
Re-verified, no change to tracked fields
2022-01-13
Study Status, Contacts/Locations v10
Study sites88→89
2021-11-05
Study Status, Contacts/Locations v9
Study sitescontacts updated at 1 of 88 sites
2021-11-01
Study Status, Contacts/Locations v8
Study sites84→88
2021-08-06
Study Status, Contacts/Locations v7
Study sitesdetails revised at 8 of 84 sites
2021-01-12
Study Status, Contacts/Locations v6
Study sites82→84
2020-10-01
Study Status, Contacts/Locations v5
Study sites73→82
2019-10-03
Study Status, Eligibility, Contacts/Locations v4
Primary completion date2025-12→2027-12
Completion date2025-12→2027-12
Study sites59→73
Eligibility criteria-21 characters
Inclusion Criteria: • Subjects with a PFO who have had an ischemic stroke within the last 270547 days Exclusion Criteria: Atherosclerosis or other arteriopa [...] the intracranial and extracranial vessels associated with a >≥ 50% lumen diameter supplying the involved lesion Intra-card [...] hypercoagulable states; Anticardiolipin Ab of the IgG or IgM (≥30), Lupus anticoagulant, B2-glycoprotein-1 antibodies (≥30) or persistently elevated fasting plasma homocysteine despite medical therapy(>20) Unable to take antiplatelet therapy Anatomy in which the AM [...]
2019-01-31
Study Status v3
Re-verified, no change to tracked fields
2018-10-15
Study Status, Contacts/Locations v2
Study sites25→59
2018-05-01
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2017-12→confirmed 2018-01-04
Study sites1→25
2017-10-12
Original filing
Abbott Medical Devices
84 trials monitored
See 2 trials at risk
Stroke
3,268 trials monitored
See 122 trials at risk
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.
Trial Details
NCT Number NCT03309332
Lead Sponsor Abbott Medical Devices
Conditions Stroke, Patent Foramen Ovale
Enrollment 1,214 participants
Start Date 2018-01-31
Primary Completion 2030-02-05 (estimated)
Study Completion 2030-02-05 (estimated)
Updated on ClinicalTrials.gov 2026-03-11