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

NCT05213104 | Active Not Recruiting Phase 3 DMC

• 2 other identifiers: APHP2011102021-002608-10
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

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

Keywords

cryptongenic stroke; Percutaneous Patent Foramen Ovale closure; randomized controlled trial; Patent Foramen Ovale; Atrial arrhythmia; Atrial Fibrillation; flecainide

Outcome Measures

Primary Outcomes (1)

• percentage of patients with at least one episode of atrial arrythmia

  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

  within 3 months after PFO closure

Secondary Outcomes (1)

• percentage of patients with at least one episode of atrial arrythmia(AA)

  between the 3-months and 6-months follow-up visits

Other Outcomes (6)

• percentage of patients with AA≥6 min

  within 3 months after PFO closure

• percentage of stroke or TIA

  within 6 months after PFO closure

• Percentage of non-scheduled practitioner-consultation or hospitalization for any cardiovascular reason

  within 6 months after PFO closure

Study Arms (3)

group 1 - Flecainide 150 mg 6 months

EXPERIMENTAL

Flecainide 150 mg 6 months in addition to standard of care

Drug: Flecainide

group 2 - Flecainide 150 mg 3 months

EXPERIMENTAL

Flecainide 150 mg 3 months in addition to standard of care

Drug: Flecainide

group 3 - no Flecainide

NO INTERVENTION

to receive no additional treatment (standard of care only).

Interventions

Flecainide DRUG

Flecainide 150 mg 6 months in addition to standard of care

Also known as: Flecainide Acetate 150 MG

group 1 - Flecainide 150 mg 6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• History of atrial arrhythmia (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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Fonds de Dotation ACTION: collaborator

Study Sites (1)

Hopital Pitié Salpetrière

Paris, IDF, 75013, France

Location

Related Publications (2)

• 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: 39222035 DERIVED

• 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.

  PMID: 38216511 DERIVED

MeSH Terms

Conditions

Foramen Ovale, Patent; Ischemic Stroke; Atrial Fibrillation

Interventions

Flecainide

Condition Hierarchy (Ancestors)

Heart Septal Defects, Atrial; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Giles MONTALESCOT, MD,PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: only outcomes assessor will be blinded to the study arm (PROBE design)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, controlled, open-label study with a blind evaluation of all the endpoints (PROBE design)

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: January 28, 2022
• Study Start: March 23, 2022
• Primary Completion: February 28, 2024
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)