Assessment of Flecainide to Lower the patent foramen Ovale closure risk of Atrial arrhythmia or Tachycardia

Phase 1

• Conditions: Patent Foramen Ovale Closure Atrial Arrhytmia or Tachycardia; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2024-513324-42-00
• Lead Sponsor: Assistance Publique Hopitaux De Paris

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-22
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 186

Inclusion Criteria

Patients are = 18 years of age, 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., Affiliated to Social Security, Patients 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 arrhythmia (paroxysmal, persistent or permanent), 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 (see 7.4.1), 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), 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess if flecainide is efficient to prevent atrial arrhythmia (AA) occurrence during the 3 months after PFO closure;Secondary Objective: To assess if 6 months treatment by flecainide is more efficient than 3 months treatment by flecainide to prevent AA occurrence after PFO closure Secondary Endpoint:;Primary end point(s): 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).