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Studies

Interventional Active not recruiting Phase 3

NCT05213104 on ClinicalTrials.gov

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

  • Sponsor: Assistance Publique - Hôpitaux de Paris
  • Collaborators: Fonds de Dotation ACTION
  • Enrollment: 186 (Actual)
  • Study start: 2022-03-23 (Actual)
  • Primary completion: 2024-02-28 (Actual)
  • Study completion: 2026-09-11 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: randomized, controlled, open-label study with a blind evaluation of all the endpoints (PROBE design)
  • Masking: Single (Outcomes Assessor)
  • PrimaryPurpose: Treatment

Brief Summary

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.

Conditions

  • Patent Foramen Ovale
  • Atrial Arrhythmia
  • Cryptogenic Stroke

Intervention / Treatment

  • Drug: Flecainide

Primary Outcome Measures

  • percentage of patients with at least one episode of atrial arrythmia (within 3 months after PFO closure)
    percentage of patients with at least one episode of symptomatic or asymptomatic atrial arrhythmia episodes (≥30s) recorded on long-term monitoring with an insertable cardiac monitor (ICM) during the 3 months after PFO closure Atrial arrhythmia is defined as any episode of AF, atrial flutter or atrial tachycardia that lasts 30 seconds or more, in accordance with the 2012 consensus statement from the Heart Rhythm Society and others

Countries

France

Locations and Investigators

  • Assistance Publique Hopitaux De Paris, Paris Cedex 15, France
  • Centre Hospitalier Universitaire De Caen Normandie, Caen Cedex 9, France
    • Farzin, BEYGUI
  • Centre Hospitalier Universitaire De Nimes, Nimes, France
    • Guillaume, CAYLA
  • Centre Hospitalier Universitaire De Rennes, Rennes, France
    • Vincent, AUFFREY
  • Assistance Publique Hopitaux De Paris, Paris Cedex 13, France
  • University Hospital Of Clermont-Ferrand, Clermont Ferrand Cedex 1, France
    • Claire, DAUPHIN
  • Centre Hospitalier Regional De Marseille, Marseille, France
    • Philippe, ALDEBERT
  • Centre Hospitalier Universitaire De Toulouse, Toulouse Cedex 9, France
    • Meyer, ELBAZ
  • Centre Hospitalier Universitaire De Saint Etienne, St Etienne Cedex 2, France
    • Antoine, DA COSTA
  • Centre Hospitalier Regional Universitaire De Tours, Chambray Les Tours, France
    • Jean-Michel, CLERC
  • Centre Hospitalier Universitaire D'Angers, Angers, France
    • Wissam, ABI KHALIL
  • Grand Hopital De L Est Francilien, Meaux, France
    • Simon, ELHADAD
  • Centre Hospitalier Universitaire De Montpellier, Montpellier Cedex 5, France
    • Jean-Christophe, MARCIA
  • Centre Hospitalier Universitaire De Bordeaux, Pessac, France

Study Officials