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Assessment of Flecainide to Lower the Patent Foramen Ovale Closure Risk of Atrial Fibrillation or Tachycardia (AFLOAT)

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ClinicalTrials.gov Identifier: NCT05213104
Recruitment Status : Recruiting
First Posted : January 28, 2022
Last Update Posted : September 7, 2022
Sponsor:
Collaborator:
Fonds de Dotation ACTION
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE December 20, 2021
First Posted Date  ICMJE January 28, 2022
Last Update Posted Date September 7, 2022
Actual Study Start Date  ICMJE March 23, 2022
Estimated Primary Completion Date January 19, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2022)
percentage of patients with at least one episode of atrial arrythmia [ Time Frame: within 3 months after PFO closure ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2022)
percentage of patients with at least one episode of atrial arrythmia [ Time Frame: between the 3-months and 6-months follow-up visits ]
Percentage of patients with at least one episode of symptomatic or asymptomatic AF episodes (≥30s) recorded on long-term monitoring with ICM during the 3-6 months period after PFO closure
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 14, 2022)
  • percentage of patients with AF≥6 min [ Time Frame: within 3 months after PFO closure ]
    Percentage of patients with at least one episode of symptomatic or asymptomatic AF episodes (≥6 min) recorded on long-term monitoring with ICM device during the 3 months after PFO
  • percentage of stroke or TIA [ Time Frame: within 6 months after PFO closure ]
    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
  • Percentage of non-scheduled practitioner-consultation or hospitalization for any cardiovascular reason [ Time Frame: within 6 months after PFO closure ]
    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
  • All-cause mortality [ Time Frame: within 6 months after PFO closure ]
    All-cause mortality during the 3 and 6 months after PFO closure
  • Rate of Flecainide-related adverse events [ Time Frame: from the Day 0 (V0) to the 6 months follow-up visit (V2) ]
    Rate of Flecainide-related adverse events
  • Percentage of patients with at least one episode of symptomatic or asymptomatic AF [ Time Frame: from Day 0 (V0) till the ICM explantation (up to 2.5 years) ]
    Percentage of patients with at least one episode of symptomatic or asymptomatic AF episodes (≥6 min) recorded on long-term monitoring with ICM device during the whole follow-up period until battery run out or ICM removal.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Assessment of Flecainide to Lower the Patent Foramen Ovale Closure Risk of Atrial Fibrillation or Tachycardia
Official Title  ICMJE Assessment of Flecainide to Lower the Patent Foramen Ovale Closure Risk of Atrial Fibrillation or Tachycardia
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 AF and may be useful in preventing these AF 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 AF after PFO closure. AFLOAT will be the first randomized study to possibly validate flecainide to prevent AF in these patients.

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 observational phase as long as the patient is implanted with the ICM during when only the data of the device will be collected.

Screening and selection occurs before the procedure of PFO closure and an inform consent form is signed.

During the procedure of PFO closure, a small ICM (CONFIRM RX, ABBOTT) providing a long-term monitoring is implanted to detect all AF or atrial flutter episodes.

Immediately after PFO closure, patients are randomly assigned, in a 1:1:1 ratio, in 3 groups : flecainide (150 mg per day in a single sustained-release dose) for 6 months (in addition to standard of care), flecainide (150 mg per day in a single sustained-release dose) for 3 months (in addition to standard Clinical follow-up is conducted during hospitalization, at 3 months (M3) and 6 months (M6-end-of-interventionnal phase) after discharge. A contrast echocardiography is recommended between 1 and 6 months. Telemonitoring provides notifications in case of arrhythmic event.

An observational period in patients who will keep the ICM beyond the 6-month follow-up period. Atrial fibrillation detection will be continued.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
randomized, controlled, open-label study with a blind evaluation of all the endpoints (PROBE design)
Masking: Single (Outcomes Assessor)
Masking Description:
only outcomes assessor will be blinded to the study arm (PROBE design)
Primary Purpose: Treatment
Condition  ICMJE
  • Patent Foramen Ovale
  • Atrial Fibrillation
  • Cryptogenic Stroke
Intervention  ICMJE
  • Drug: Flecainide
    Flecainide 150 mg 6 months in addition to standard of care
    Other Name: Flecainide Acetate 150 MG
  • Drug: Flecainide
    Flecainide 150 mg 3 months in addition to standard of care
    Other Name: Flecainide Acetate 150 MG
Study Arms  ICMJE
  • Experimental: group 1 - Flecainide 150 mg 6 months
    Flecainide 150 mg 6 months in addition to standard of care
    Intervention: Drug: Flecainide
  • Experimental: group 2 - Flecainide 150 mg 3 months
    Flecainide 150 mg 3 months in addition to standard of care
    Intervention: Drug: Flecainide
  • No Intervention: group 3 - no Flecainide
    to receive no additional treatment (standard of care only).
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 14, 2022)
186
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 19, 2026
Estimated Primary Completion Date January 19, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 fibrillation (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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Giles MONTALESCOT, MD,PhD +33 1 42 16 29 18 gilles.montalescot@aphp.fr
Contact: Delphine BRUGIER, PhD +33 1 42 16 29 18 delphine.brugier-ext@aphp.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05213104
Other Study ID Numbers  ICMJE APHP201110
2021-002608-10 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Assistance Publique - Hôpitaux de Paris
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Fonds de Dotation ACTION
Investigators  ICMJE
Study Chair: Giles MONTALESCOT, MD,PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date December 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP