Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2025-12-24 @ 9:17 PM
NCT ID:
NCT05213104
Eligibility Criteria:
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 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05213104
Study Brief:
Protocol Section:
NCT05213104