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Assessment of Flecainide to Lower the Patent Foramen Ovale Closure Risk of Atrial Arrhythmia or Tachycardia

Study acronym: AFLOAT
StatusActive, Not Recruiting
PhasePhase 3
Started2022-03-23
View on ClinicalTrials.gov ↗

Amendment history

2026-09-07
notable
Study Status v6
Trial status changed: Unknown → Active, Not Recruiting
Completion pushed: 2026-07 → 2026-09-11
2026-08-09
minor
Trial status changed: Active, Not Recruiting → Unknown
2024-04-04
notable
Recruiting→Unknown Study Status, Study Design, Contacts/Locations v5
Trial statusRecruiting→Unknown
Primary completion dateestimated 2024-01-19→confirmed 2024-02-28
Completion date2026-07-19→2026-07
Study sitesdetails revised at 1 of 1 site
2023-07-31
minor
Study Identification, Study Status, Study Description, Conditions, Outcome Measures, Eligibility v4
Eligibility criteria-2 characters
[...] y major complications Exclusion Criteria: History of atrial fibrillationarrhythmia (paroxysmal, persistent or permanent) Electrocardiographic [...]
Secondary endpoints1 entry, revised
percentage of patients with at least one episode of atrial arrythmia(AA)
Study description-20 characters
[...] providing a long-term monitoring is implanted to detect all AF or atrial flutterAA episodes. Immediately after PFO closure, patients are rando [...] ll keep the ICM beyond the 6-month follow-up period. Atrial fibrillationarrhythmia detection will be continued.
Study title-2 characters
Assessment of Flecainide to Lower the Patent Foramen Ovale Closure Risk of Atrial FibrillationArrhythmia or Tachycardia
2022-09-06
notable
Enrolling by Invitation→Recruiting Study Status, Contacts/Locations v3
Trial statusEnrolling by Invitation→Recruiting
Study sitesdetails revised at 1 of 1 site
Show 2 earlier versions
2022-07-22
notable
Not Yet Recruiting→Enrolling by Invitation Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Enrolling by Invitation
Start dateestimated 2022-03-10→confirmed 2022-03-23
Study sitescontacts updated at 1 of 1 site
2022-02-17
minor
Study Status, Study Description v1
Start date2022-01-19→2022-03-10
2022-01-14
minor
Original filing
About 30% of ischemic strokes are cryptogenic. Patent Foramen Ovale (PFO) is present in about 25% of the general population. In cryptogenic strokes, PFO has been shown to be overrepresented and recent intervention studies have confirmed that PFO has a causal link with stroke. In patients with recent cryptogenic stroke, these randomized studies have shown at least 50%-reduction of recurrent neurological events after PFO percutaneous closure compared with medical therapy alone. At the The risk of AF reported in these studies in certainly largely underestimated as only symptomatic and recorded episodes of AF have been declared. Patients often report palpitations without a dia gnosis of AF made on the ECG or a Holter. Long term ECG monitoring provides more accurate data on AF incidence. Administration of flecainide has been shown to be effective in preventing Atrial arrhythmia and may be useful in preventing these Atrial arrhythmia(AA) episodes after PFO closure. To the knowledge of the investigators, there is no study assessing the efficacy of any antiarrhythmic drug in the prevention of AFafter PFO closure. AFLOAT will be the first randomized study to possibly validate flecainide to prevent Atrial arrhythmia in these patients.
Trial Details
NCT Number NCT05213104
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators: Fonds de Dotation ACTION
Conditions Patent Foramen Ovale, Atrial Arrhythmia, Cryptogenic Stroke
Enrollment 186 participants
Start Date 2022-03-23
Primary Completion 2024-02-28 (estimated)
Study Completion 2026-09-11 (estimated)
Updated on ClinicalTrials.gov 2026-09-09