Assessment of Flecainide to Lower the Patent Foramen Ovale Closure Risk of Atrial Fibrillation or Tachycardia (AFLOAT)
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| ClinicalTrials.gov Identifier: NCT05213104 |
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Recruitment Status :
Recruiting
First Posted : January 28, 2022
Last Update Posted : September 7, 2022
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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 AF and may be useful in preventing these AF 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 AF after PFO closure. AFLOAT will be the first randomized study to possibly validate flecainide to prevent AF in these patients.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Patent Foramen Ovale Atrial Fibrillation Cryptogenic Stroke | Drug: Flecainide | Phase 3 |
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 AF or atrial flutter 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 fibrillation detection will be continued.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 186 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | randomized, controlled, open-label study with a blind evaluation of all the endpoints (PROBE design) |
| Masking: | Single (Outcomes Assessor) |
| Masking Description: | only outcomes assessor will be blinded to the study arm (PROBE design) |
| Primary Purpose: | Treatment |
| Official Title: | Assessment of Flecainide to Lower the Patent Foramen Ovale Closure Risk of Atrial Fibrillation or Tachycardia |
| Actual Study Start Date : | March 23, 2022 |
| Estimated Primary Completion Date : | January 19, 2024 |
| Estimated Study Completion Date : | July 19, 2026 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: group 1 - Flecainide 150 mg 6 months
Flecainide 150 mg 6 months in addition to standard of care
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Drug: Flecainide
Flecainide 150 mg 6 months in addition to standard of care
Other Name: Flecainide Acetate 150 MG |
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Experimental: group 2 - Flecainide 150 mg 3 months
Flecainide 150 mg 3 months in addition to standard of care
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Drug: Flecainide
Flecainide 150 mg 3 months in addition to standard of care
Other Name: Flecainide Acetate 150 MG |
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No Intervention: group 3 - no Flecainide
to receive no additional treatment (standard of care only).
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- percentage of patients with at least one episode of atrial arrythmia [ Time Frame: 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
- percentage of patients with at least one episode of atrial arrythmia [ Time Frame: between the 3-months and 6-months follow-up visits ]Percentage of patients with at least one episode of symptomatic or asymptomatic AF episodes (≥30s) recorded on long-term monitoring with ICM during the 3-6 months period after PFO closure
- percentage of patients with AF≥6 min [ Time Frame: within 3 months after PFO closure ]Percentage of patients with at least one episode of symptomatic or asymptomatic AF episodes (≥6 min) recorded on long-term monitoring with ICM device during the 3 months after PFO
- percentage of stroke or TIA [ Time Frame: within 6 months after PFO closure ]Percentage of patients with at least one episode of fatal or non-fatal stroke or Transient Ischemic Attack (TIA) during the 3 and 6 months after PFO closure
- Percentage of non-scheduled practitioner-consultation or hospitalization for any cardiovascular reason [ Time Frame: within 6 months after PFO closure ]Percentage of patients with at least one episode of non-scheduled practitioner-consultation or hospitalization for any cardiovascular reason during the 3 and 6 months after PFO closure
- All-cause mortality [ Time Frame: within 6 months after PFO closure ]All-cause mortality during the 3 and 6 months after PFO closure
- Rate of Flecainide-related adverse events [ Time Frame: from the Day 0 (V0) to the 6 months follow-up visit (V2) ]Rate of Flecainide-related adverse events
- Percentage of patients with at least one episode of symptomatic or asymptomatic AF [ Time Frame: from Day 0 (V0) till the ICM explantation (up to 2.5 years) ]Percentage of patients with at least one episode of symptomatic or asymptomatic AF episodes (≥6 min) recorded on long-term monitoring with ICM device during the whole follow-up period until battery run out or ICM removal.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- ≥ 18 years of age
- They are candidates for a procedure of PFO closure, whatever the indication (secondary prevention of stroke, platypnoea, decompression illness…). The indication must have been confirmed by a multidisciplinary team as recommended by the Haute Autorité de Santé.
- They are affiliated to Social Security
- They have provided a signed written consent form ICM implantation and randomization will occur only in patients with successful PFO closure without any major complications
Exclusion Criteria:
- History of atrial fibrillation (paroxysmal, persistent or permanent)
- Electrocardiographic of ventricular pre-excitation or bundle-branch block (QRS >120ms)
- Ischemic heart disease
- Dilated or hypertrophic cardiomyopathy
- A history of heart failure, severe valvular heart disease, left ventricular dysfunction (ejection fraction <50 percent)
- A long QT interval or Brugada syndrome
- The bradycardia-tachycardia syndrome (resting heart rate, ≤50 beats per minute, or repetitive sinoatrial blocks during waking hours)
- Documentation of previous episodes of second or third-degree atrioventricular block
- High heart rate at baseline > 100 bmp
- Renal insufficiency (Glomerular filtration rate estimated by the Cockroft and Gault formula <30ml/min/m2),
- Previous hypokalemia (potassium level <3 mmol per liter)
- Suspected or known pregnancy (woman of childbearing potential must undergo a pregnancy test)
- A known hypersensibility to flecainide or its excipients
- Contemporaneous enrollment in an interventional clinical trial
- Intended use of a prohibited medication
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05213104
| Contact: Giles MONTALESCOT, MD,PhD | +33 1 42 16 29 18 | gilles.montalescot@aphp.fr | |
| Contact: Delphine BRUGIER, PhD | +33 1 42 16 29 18 | delphine.brugier-ext@aphp.fr |
| France | |
| Hopital Pitié Salpetrière | Recruiting |
| Paris, IDF, France, 75013 | |
| Contact: Giles Montalescot, MD, PhD +33 1 42 16 29 18 gilles.montalescot@aphp.fr | |
| Contact: Delphine Brugier, PhD +33 1 42 16 29 18 delphine.brugier-ext@aphp.fr | |
| Study Chair: | Giles MONTALESCOT, MD,PhD | Assistance Publique - Hôpitaux de Paris |
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT05213104 |
| Other Study ID Numbers: |
APHP201110 2021-002608-10 ( EudraCT Number ) |
| First Posted: | January 28, 2022 Key Record Dates |
| Last Update Posted: | September 7, 2022 |
| Last Verified: | December 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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cryptongenic stroke Percutaneous Patent Foramen Ovale closure randomized controlled trial Patent Foramen Ovale |
arrythmia Atrial Fibrillation flecainide |
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Ischemic Stroke Atrial Fibrillation Tachycardia Foramen Ovale, Patent Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Arrhythmias, Cardiac Heart Diseases |
Pathologic Processes Cardiac Conduction System Disease Heart Septal Defects, Atrial Heart Septal Defects Heart Defects, Congenital Cardiovascular Abnormalities Congenital Abnormalities Flecainide Anti-Arrhythmia Agents Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |