Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2025-12-28 @ 1:00 PM
Study NCT ID:
NCT05213104
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-05
First Post:
2021-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Flecainide to Lower the Patent Foramen Ovale Closure Risk of Atrial Arrhythmia or Tachycardia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054092', 'term': 'Foramen Ovale, Patent'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D006344', 'term': 'Heart Septal Defects, Atrial'}, {'id': 'D006343', 'term': 'Heart Septal Defects'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005424', 'term': 'Flecainide'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'only outcomes assessor will be blinded to the study arm (PROBE design)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized, controlled, open-label study with a blind evaluation of all the endpoints (PROBE design)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 186}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-03-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-04', 'studyFirstSubmitDate': '2021-12-20', 'studyFirstSubmitQcDate': '2022-01-14', 'lastUpdatePostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'percentage of patients with AA≥6 min', 'timeFrame': 'within 3 months after PFO closure', 'description': 'Percentage of patients with at least one episode of symptomatic or asymptomatic AA (≥6 min) recorded on long-term monitoring with ICM device during the 3 months after PFO closure'}, {'measure': 'percentage of stroke or TIA', 'timeFrame': 'within 6 months after PFO closure', 'description': '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'}, {'measure': 'Percentage of non-scheduled practitioner-consultation or hospitalization for any cardiovascular reason', 'timeFrame': 'within 6 months after PFO closure', 'description': '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'}, {'measure': 'All-cause mortality', 'timeFrame': 'within 6 months after PFO closure', 'description': 'All-cause mortality during the 3 and 6 months after PFO closure'}, {'measure': 'Rate of Flecainide-related adverse events', 'timeFrame': 'from the Day 0 (V0) to the 6 months follow-up visit (V2)', 'description': 'Rate of Flecainide-related adverse events'}, {'measure': 'Percentage of patients with at least one episode of symptomatic or asymptomatic AA', 'timeFrame': 'from Day 0 (V0) till the ICM explantation (up to 2.5 years)', 'description': 'Percentage of patients with at least one episode of symptomatic or asymptomatic AA episodes (≥6 min) recorded on long-term monitoring with ICM device during the whole follow-up period until battery run out or ICM removal.'}], 'primaryOutcomes': [{'measure': 'percentage of patients with at least one episode of atrial arrythmia', 'timeFrame': 'within 3 months after PFO closure', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'percentage of patients with at least one episode of atrial arrythmia(AA)', 'timeFrame': 'between the 3-months and 6-months follow-up visits', 'description': 'Percentage of patients with at least one episode of symptomatic or asymptomatic AA (≥30s) recorded on long-term monitoring with ICM between 3 and 6 months after PFO closure'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cryptongenic stroke', 'Percutaneous Patent Foramen Ovale closure', 'randomized controlled trial', 'Patent Foramen Ovale', 'Atrial arrhythmia', 'Atrial Fibrillation', 'flecainide'], 'conditions': ['Patent Foramen Ovale', 'Atrial Arrhythmia', 'Cryptogenic Stroke']}, 'referencesModule': {'references': [{'pmid': '39222035', 'type': 'DERIVED', 'citation': 'Hauguel-Moreau M, Guedeney P, Dauphin C, Auffret V, Clerc JM, Marijon E, Elbaz M, Aldebert P, Beygui F, Abi Khalil W, Da Costa A, Macia JC, Elhadad S, Cayla G, Iriart X, Laredo M, Rolland T, Temmar Y, Gheorghiu ME, Brugier D, Silvain J, Hammoudi N, Duthoit G, Diallo A, Vicaut E, Montalescot G; ACTION Study Group. Flecainide to Prevent Atrial Arrhythmia After Patent Foramen Ovale Closure: AFLOAT Study, A Randomized Clinical Trial. Circulation. 2024 Nov 19;150(21):1659-1668. doi: 10.1161/CIRCULATIONAHA.124.071186. Epub 2024 Sep 2.'}, {'pmid': '38216511', 'type': 'DERIVED', 'citation': 'Hauguel-Moreau M, Guedeney P, Dauphin C, Auffret V, Marijon E, Aldebert P, Clerc JM, Beygui F, Elbaz M, Khalil WA, Da Costa A, Macia JC, Elhadad S, Cayla G, Brugier D, Silvain J, Hammoudi N, Duthoit G, Vicaut E, Montalescot G; ACTION Study Group. Flecainide to prevent atrial arrhythmia after patent foramen ovale closure, Rationale and design of the randomized AFLOAT study. Eur Heart J Cardiovasc Pharmacother. 2024 May 4;10(3):184-189. doi: 10.1093/ehjcvp/pvad100.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nAdministration 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.\n\nTo 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.', 'detailedDescription': 'AFLOAT is a national, multicenter, randomized, controlled, open-label superiority study with a blind evaluation of all the endpoints (PROBE design).\n\nThe 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.\n\nScreening and selection occurs before the procedure of PFO closure and an inform consent form is signed.\n\nDuring the procedure of PFO closure, a small ICM (CONFIRM RX, ABBOTT) providing a long-term monitoring is implanted to detect all AA episodes.\n\nImmediately 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.\n\nAn observational period in patients who will keep the ICM beyond the 6-month follow-up period. Atrial arrhythmia detection will be continued.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 18 years of age\n* 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.\n* They are affiliated to Social Security\n* 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\n\nExclusion Criteria:\n\n* History of atrial arrhythmia (paroxysmal, persistent or permanent)\n* Electrocardiographic of ventricular pre-excitation or bundle-branch block (QRS \\>120ms)\n* Ischemic heart disease\n* Dilated or hypertrophic cardiomyopathy\n* A history of heart failure, severe valvular heart disease, left ventricular dysfunction (ejection fraction \\<50 percent)\n* A long QT interval or Brugada syndrome\n* The bradycardia-tachycardia syndrome (resting heart rate, ≤50 beats per minute, or repetitive sinoatrial blocks during waking hours)\n* Documentation of previous episodes of second or third-degree atrioventricular block\n* High heart rate at baseline \\> 100 bmp\n* Renal insufficiency (Glomerular filtration rate estimated by the Cockroft and Gault formula \\<30ml/min/m2),\n* Previous hypokalemia (potassium level \\<3 mmol per liter)\n* Suspected or known pregnancy (woman of childbearing potential must undergo a pregnancy test)\n* A known hypersensibility to flecainide or its excipients\n* Contemporaneous enrollment in an interventional clinical trial\n* Intended use of a prohibited medication'}, 'identificationModule': {'nctId': 'NCT05213104', 'acronym': 'AFLOAT', 'briefTitle': 'Assessment of Flecainide to Lower the Patent Foramen Ovale Closure Risk of Atrial Arrhythmia or Tachycardia', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Assessment of Flecainide to Lower the Patent Foramen Ovale Closure Risk of Atrial Arrhythmia or Tachycardia', 'orgStudyIdInfo': {'id': 'APHP201110'}, 'secondaryIdInfos': [{'id': '2021-002608-10', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group 1 - Flecainide 150 mg 6 months', 'description': 'Flecainide 150 mg 6 months in addition to standard of care', 'interventionNames': ['Drug: Flecainide']}, {'type': 'EXPERIMENTAL', 'label': 'group 2 - Flecainide 150 mg 3 months', 'description': 'Flecainide 150 mg 3 months in addition to standard of care', 'interventionNames': ['Drug: Flecainide']}, {'type': 'NO_INTERVENTION', 'label': 'group 3 - no Flecainide', 'description': 'to receive no additional treatment (standard of care only).'}], 'interventions': [{'name': 'Flecainide', 'type': 'DRUG', 'otherNames': ['Flecainide Acetate 150 MG'], 'description': 'Flecainide 150 mg 6 months in addition to standard of care', 'armGroupLabels': ['group 1 - Flecainide 150 mg 6 months']}, {'name': 'Flecainide', 'type': 'DRUG', 'otherNames': ['Flecainide Acetate 150 MG'], 'description': 'Flecainide 150 mg 3 months in addition to standard of care', 'armGroupLabels': ['group 2 - Flecainide 150 mg 3 months']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'state': 'IDF', 'country': 'France', 'facility': 'Hopital Pitié Salpetrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Giles MONTALESCOT, MD,PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fonds de Dotation ACTION', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}