Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

AFLOAT is a national, multicenter, randomized, controlled, open-label superiority study with a blind evaluation of all the endpoints (PROBE design). The interventional phase is followed by an observational phase as long as the patient is implanted with the ICM during when only the data of the device will be collected. Screening and selection occurs before the procedure of PFO closure and an inform consent form is signed. During the procedure of PFO closure, a small ICM (CONFIRM RX, ABBOTT) providing a long-term monitoring is implanted to detect all AA episodes. Immediately after PFO closure, patients are randomly assigned, in a 1:1:1 ratio, in 3 groups : flecainide (150 mg per day in a single sustained-release dose) for 6 months (in addition to standard of care), flecainide (150 mg per day in a single sustained-release dose) for 3 months (in addition to standard Clinical follow-up is conducted during hospitalization, at 3 months (M3) and 6 months (M6-end-of-interventionnal phase) after discharge. A contrast echocardiography is recommended between 1 and 6 months. Telemonitoring provides notifications in case of arrhythmic event. An observational period in patients who will keep the ICM beyond the 6-month follow-up period. Atrial arrhythmia detection will be continued. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05213104
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact
Status Active, not recruiting
Phase Phase 3
Start date March 23, 2022
Completion date July 2026

See also
  Status Clinical Trial Phase
Completed NCT06192173 - Patent Foramen Ovale Closure in Migraine
Recruiting NCT04610463 - Evaluation of the Severity of Right to Left Shunt in PFO Patients After Systemic Embolism N/A
Completed NCT02882815 - Post Market Clinical Follow-up Study of IrisFITTM PFO (Patent Foramen Ovale) Occluder N/A
Completed NCT04604015 - RoBotic TCD Ultrasound BubbLe Study Compared to Transthoracic Echocardiography for Detection of Right to Left Shunt N/A
Active, not recruiting NCT04950192 - Philips Intracardiac Echocardiography (ICE) Clinical Registry
Not yet recruiting NCT04549272 - Assessment of Early Vascular Damage With Advanced Neuroimaging in Patient With Patent Foramen Ovale
Completed NCT02621528 - Lifetech CeraFlex™ Post-Market Surveillance Study N/A
Terminated NCT01018355 - The Effect of Device Closure of Patent Foramen Ovale in Elderly Patients With Crytogenic Stoke/TCI N/A
Completed NCT00831259 - Risk of Stroke in Pulmonary Embolism With a Patent Foramen Ovale (PFO) N/A
Not yet recruiting NCT05360771 - Study on the Safety and Effectiveness of the SnowyTM PFO Closure System N/A
Recruiting NCT05546320 - Comparison of the Effect of Medication Therapy in Alleviating Migraine With Patent Foramen Ovale Phase 4
Recruiting NCT05561660 - COMParison of the EffecT of dEvice Closure in Alleviating Migraine With PFO (COMPETE-2) Phase 4
Completed NCT03904277 - Does Patent Foramen Ovale Size Matter in Men and Women
Recruiting NCT06120270 - CeraFlex PFO Closure System PMCF Study
Terminated NCT01773252 - Right to Left Cardiac Shunt Detection Phase 3
Completed NCT01216423 - Pulmonary Embolism and Stroke in Patient With Patent Foramen Ovale N/A
Completed NCT03377465 - Biomarkers, Hemodynamic and Echocardiographic Predictors of Ischemic Strokes and Their Influence on the Course and Prognosis N/A
Active, not recruiting NCT04738071 - International Multicenter Patent foRamen OVale & strokE (IMPROVE) Registry
Not yet recruiting NCT06413147 - Long-term Procedural and Device Related Complications of PFO Closure
Not yet recruiting NCT06344494 - Cardiac Interventional ICE Imaging Trial N/A