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

Primary Purpose

Patent Foramen Ovale, Atrial Arrhythmia, Cryptogenic Stroke

Status

Recruiting

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

Flecainide

About this trial

This is an interventional treatment trial for Patent Foramen Ovale focused on measuring cryptongenic stroke, Percutaneous Patent Foramen Ovale closure, randomized controlled trial, Patent Foramen Ovale, Atrial arrhythmia, Atrial Fibrillation, flecainide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hopital Pitié SalpetrièreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

group 1 - Flecainide 150 mg 6 months

group 2 - Flecainide 150 mg 3 months

group 3 - no Flecainide

Arm Description

Flecainide 150 mg 6 months in addition to standard of care

Flecainide 150 mg 3 months in addition to standard of care

to receive no additional treatment (standard of care only).

Outcomes

Primary Outcome Measures

percentage of patients with at least one episode of atrial arrythmia

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

Secondary Outcome Measures

percentage of patients with at least one episode of atrial arrythmia(AA)

Percentage of patients with at least one episode of symptomatic or asymptomatic AA (≥30s) recorded on long-term monitoring with ICM between 3 and 6 months after PFO closure

Full Information

NCT ID

NCT05213104

First Posted

December 20, 2021

Last Updated

July 31, 2023

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Fonds de Dotation ACTION

1. Study Identification

Unique Protocol Identification Number

NCT05213104

Brief Title

Assessment of Flecainide to Lower the Patent Foramen Ovale Closure Risk of Atrial Arrhythmia or Tachycardia

Acronym

AFLOAT

Official Title

Assessment of Flecainide to Lower the Patent Foramen Ovale Closure Risk of Atrial Arrhythmia or Tachycardia

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 23, 2022 (Actual)

Primary Completion Date

January 19, 2024 (Anticipated)

Study Completion Date

July 19, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Fonds de Dotation ACTION

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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 Atrial arrhythmia and may be useful in preventing these Atrial arrhythmia(AA) 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 AFafter PFO closure. AFLOAT will be the first randomized study to possibly validate flecainide to prevent Atrial arrhythmia 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 AA 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 arrhythmia detection will be continued.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Patent Foramen Ovale, Atrial Arrhythmia, Cryptogenic Stroke

Keywords

cryptongenic stroke, Percutaneous Patent Foramen Ovale closure, randomized controlled trial, Patent Foramen Ovale, Atrial arrhythmia, Atrial Fibrillation, flecainide

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

randomized, controlled, open-label study with a blind evaluation of all the endpoints (PROBE design)

Masking

Outcomes Assessor

Masking Description

only outcomes assessor will be blinded to the study arm (PROBE design)

Allocation

Randomized

Enrollment

186 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

group 1 - Flecainide 150 mg 6 months

Arm Type

Experimental

Arm Description

Flecainide 150 mg 6 months in addition to standard of care

Arm Title

group 2 - Flecainide 150 mg 3 months

Arm Type

Experimental

Arm Description

Flecainide 150 mg 3 months in addition to standard of care

Arm Title

group 3 - no Flecainide

Arm Type

No Intervention

Arm Description

to receive no additional treatment (standard of care only).

Intervention Type

Drug

Intervention Name(s)

Flecainide

Other Intervention Name(s)

Flecainide Acetate 150 MG

Intervention Description

Flecainide 150 mg 6 months in addition to standard of care

Intervention Type

Drug

Intervention Name(s)

Flecainide

Other Intervention Name(s)

Flecainide Acetate 150 MG

Intervention Description

Flecainide 150 mg 3 months in addition to standard of care

Primary Outcome Measure Information:

Title

percentage of patients with at least one episode of atrial arrythmia

Description

Time Frame

within 3 months after PFO closure

Secondary Outcome Measure Information:

Title

percentage of patients with at least one episode of atrial arrythmia(AA)

Description

Percentage of patients with at least one episode of symptomatic or asymptomatic AA (≥30s) recorded on long-term monitoring with ICM between 3 and 6 months after PFO closure

Time Frame

between the 3-months and 6-months follow-up visits

Other Pre-specified Outcome Measures:

Title

percentage of patients with AA≥6 min

Description

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

Time Frame

within 3 months after PFO closure

Title

percentage of stroke or TIA

Description

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

Time Frame

within 6 months after PFO closure

Title

Percentage of non-scheduled practitioner-consultation or hospitalization for any cardiovascular reason

Description

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

Time Frame

within 6 months after PFO closure

Title

All-cause mortality

Description

All-cause mortality during the 3 and 6 months after PFO closure

Time Frame

within 6 months after PFO closure

Title

Rate of Flecainide-related adverse events

Description

Rate of Flecainide-related adverse events

Time Frame

from the Day 0 (V0) to the 6 months follow-up visit (V2)

Title

Percentage of patients with at least one episode of symptomatic or asymptomatic AA

Description

Percentage of patients with at least one episode of symptomatic or asymptomatic AA episodes (≥6 min) recorded on long-term monitoring with ICM device during the whole follow-up period until battery run out or ICM removal.

Time Frame

from Day 0 (V0) till the ICM explantation (up to 2.5 years)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Giles MONTALESCOT, MD,PhD

Phone

+33 1 42 16 29 18

gilles.montalescot@aphp.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Delphine BRUGIER, PhD

Phone

+33 1 42 16 29 18

delphine.brugier-ext@aphp.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Giles MONTALESCOT, MD,PhD

Organizational Affiliation

Assistance Publique - Hôpitaux de Paris

Official's Role

Study Chair

Facility Information:

Facility Name

Hopital Pitié Salpetrière

City

Paris

State/Province

IDF

ZIP/Postal Code

75013

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Giles Montalescot, MD, PhD

Phone

+33 1 42 16 29 18

gilles.montalescot@aphp.fr

First Name & Middle Initial & Last Name & Degree

Delphine Brugier, PhD

Phone

+33 1 42 16 29 18

delphine.brugier-ext@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Assessment of Flecainide to Lower the Patent Foramen Ovale Closure Risk of Atrial Arrhythmia or Tachycardia

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