Flecainide for Patent foramen ovale | Atrial arrhythmia (including atrial fibrillation, atrial flutter and atrial tachycardia)

Inclusion criteria

• {"criterion_text":"- Patients are ≥ 18 years of age\n- 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- Affiliated to Social Security\n- Patients have provided a signed written consent form\n- ICM implantation and randomization will occur only in patients with successful PFO closure without any major complications"}

Exclusion criteria

• {"criterion_text":"- History of atrial arrhythmia (paroxysmal, persistent or permanent)\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 (see 7.4.1)\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- 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"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint of the study will be a blind evaluation of the percentage of patients with at least one episode of symptomatic or asymptomatic AA (≥30s) recorded on long-term monitoring with an insertable cardiac monitor (ICM) during the 3 months after PFO closure AA 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 (1).","definition_or_measurement_approach":"Blind evaluation of percentage of patients with ≥1 episode of symptomatic or asymptomatic atrial arrhythmia (AA) lasting ≥30 seconds recorded by long-term monitoring with an insertable cardiac monitor (ICM) during the 3 months after PFO closure. AA defined as any episode of AF, atrial flutter or atrial tachycardia lasting 30 seconds or more per 2012 Heart Rhythm Society consensus."}

Secondary endpoints

• {"endpoint_text":"- Percentage of patients with at least one episode of symptomatic or asymptomatic AA (≥30s) recorded on long-term monitoring with ICM during the 3-6 months period after PFO closure","definition_or_measurement_approach":"Recorded by long-term ICM monitoring during months 3–6 after PFO closure; proportion of patients with ≥1 AA episode ≥30s."}
• {"endpoint_text":"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","definition_or_measurement_approach":"Recorded by long-term ICM monitoring during 3 months after PFO closure; proportion with ≥1 AA episode ≥6 minutes."}
• {"endpoint_text":"AA burden and its evolution over time","definition_or_measurement_approach":"Assessment of AA burden (duration/frequency) over follow-up as measured by ICM recordings."}
• {"endpoint_text":"Percentage of patients with at least one episode of symptomatic palpitations during the 3 and 6 months after PFO closure","definition_or_measurement_approach":"Patient-reported symptomatic palpitations occurrence recorded at 3- and 6-month assessments."}
• {"endpoint_text":"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","definition_or_measurement_approach":"Occurrence of fatal/non-fatal stroke or TIA recorded during 3- and 6-month follow-up."}
• {"endpoint_text":"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","definition_or_measurement_approach":"Unscheduled cardiovascular consultations or hospitalizations tracked during 3- and 6-month follow-up."}
• {"endpoint_text":"All-cause mortality during the 3 and 6 months after PFO closure","definition_or_measurement_approach":"All-cause death events recorded during 3- and 6-month follow-up."}
• {"endpoint_text":"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 whole follow-up period until battery run out or ICM removal.","definition_or_measurement_approach":"Recorded by long-term ICM over entire implantation period until battery depletion or device removal; proportion with ≥1 AA episode ≥6 minutes."}
• {"endpoint_text":"Rate of Flecainide-related adverse events","definition_or_measurement_approach":"Incidence rate of adverse events judged related to flecainide during treatment/follow-up."}

France

Earliest CTIS Part Ii Submission Date

02-05-2024

Latest Decision Or Authorization Date

23-05-2024

Processing Time Days

21

Number Of Sites

14

Number Of Participants

186

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France