Status:
ACTIVE_NOT_RECRUITING
Assessment of Flecainide to Lower the Patent Foramen Ovale Closure Risk of Atrial Arrhythmia or Tachycardia
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Fonds de Dotation ACTION
Conditions:
Patent Foramen Ovale
Atrial Arrhythmia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Detailed Description
AFLOAT is a national, multicenter, randomized, controlled, open-label superiority study with a blind evaluation of all the endpoints (PROBE design). The interventional phase is followed by an observa...
Eligibility Criteria
Inclusion
- ≥ 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
- 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
Key Trial Info
Start Date :
March 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2026
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT05213104
Start Date
March 23 2022
End Date
July 1 2026
Last Update
April 5 2024
Active Locations (1)
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1
Hopital Pitié Salpetrière
Paris, IDF, France, 75013