Patent Foramen OvalePhase 3AFLOATNCT05213104
Assessment of Flecainide to Lower the Patent Foramen Ovale Closure Risk of Atrial Arrhythmia or Tachycardia
A Phase 3 study testing Flecainide in people with Patent Foramen Ovale and Atrial Arrhythmia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patent Foramen Ovale, Atrial Arrhythmia, Cryptogenic Stroke
- What is being tested?
- Flecainide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteFrance
- Study dates
- 23 Mar 2022to 11 Sep 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Patent Foramen Ovale, Atrial Arrhythmia, Cryptogenic Stroke
- Being tested
- Flecainide
- Keywords
- cryptongenic stroke, Percutaneous Patent Foramen Ovale closure, randomized controlled trial, Patent Foramen Ovale, Atrial arrhythmia, Atrial Fibrillation, flecainide
- Medical subject headings
- Foramen Ovale, Patent, Ischemic Stroke, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlecainideDrug
Also called Flecainide Acetate 150 MG
Flecainide 150 mg 6 months in addition to standard of care
FlecainideDrug
Also called Flecainide Acetate 150 MG
Flecainide 150 mg 3 months in addition to standard of care
| Study group | Role | What they receive |
|---|---|---|
| group 1 - Flecainide 150 mg 6 months | Experimental | Flecainide 150 mg 6 months in addition to standard of care Receives: Drug: Flecainide |
| group 2 - Flecainide 150 mg 3 months | Experimental | Flecainide 150 mg 3 months in addition to standard of care Receives: Drug: Flecainide |
| group 3 - no Flecainide | No intervention | to receive no additional treatment (standard of care only). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 3 months after PFO closure
Secondary outcomes (1)
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
Measured: between the 3-months and 6-months follow-up visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start23 Mar 2022
- Primary completion28 Feb 2024
- Study completion11 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Patent Foramen OvaleStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, controlled, open-label study with a blind evaluation of all the endpoints (PROBE design)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds de Dotation ACTION
- Responsible party
- Sponsor
- Investigators
- Giles MONTALESCOT, MD,PhD, Study chair, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05213104
- Sponsor's protocol ID
- APHP201110
- Other IDs
- 2021-002608-10
- Acronym
- AFLOAT
- Status last verified
- Sep 2026
- First submitted
- 20 Dec 2021
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hauguel-Moreau M, Guedeney P, Dauphin C, Auffret V, Clerc JM, Marijon E, Elbaz M, Aldebert P, Beygui F, Abi Khalil W, Da Costa A, Macia JC, Elhadad S, Cayla G, Iriart X, Laredo M, Rolland T, Temmar Y, Gheorghiu ME, Brugier D, Silvain J, Hammoudi N, Duthoit G, Diallo A, Vicaut E, Montalescot G; ACTION Study Group. Flecainide to Prevent Atrial Arrhythmia After Patent Foramen Ovale Closure: AFLOAT Study, A Randomized Clinical Trial. Circulation. 2024 Nov 19;150(21):1659-1668. doi: 10.1161/CIRCULATIONAHA.124.071186. Epub 2024 Sep 2.
PubMed 39222035Hauguel-Moreau M, Guedeney P, Dauphin C, Auffret V, Marijon E, Aldebert P, Clerc JM, Beygui F, Elbaz M, Khalil WA, Da Costa A, Macia JC, Elhadad S, Cayla G, Brugier D, Silvain J, Hammoudi N, Duthoit G, Vicaut E, Montalescot G; ACTION Study Group. Flecainide to prevent atrial arrhythmia after patent foramen ovale closure, Rationale and design of the randomized AFLOAT study. Eur Heart J Cardiovasc Pharmacother. 2024 May 4;10(3):184-189. doi: 10.1093/ehjcvp/pvad100.
PubMed 38216511
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Flecainide to Lower the Patent Foramen Ovale Closure Risk of Atrial Arrhythmia or Tachycardia
- ClinicalTrials.gov ID
- NCT05213104
- Acronym / sponsor ID
- AFLOAT / APHP201110
- Conditions
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Fonds de Dotation ACTION
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 11 Sep 2026 (estimated)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- randomized, controlled, open-label study with a blind evaluation of all the endpoints (PROBE design)
| Arm | Type | Receives |
|---|---|---|
| group 1 - Flecainide 150 mg 6 months | Experimental | Drug: FlecainideFlecainide 150 mg 6 months in addition to standard of care |
| group 2 - Flecainide 150 mg 3 months | Experimental | Drug: FlecainideFlecainide 150 mg 3 months in addition to standard of care |
| group 3 - no Flecainide | No intervention | –to receive no additional treatment (standard of care only). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FlecainideAlso: Flecainide Acetate 150 MGFlecainide 150 mg 6 months in addition to standard of care | Drug | group 1 - Flecainide 150 mg 6 months |
| FlecainideAlso: Flecainide Acetate 150 MGFlecainide 150 mg 3 months in addition to standard of care | Drug | group 2 - Flecainide 150 mg 3 months |
Primary outcome
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
1 secondary outcome
percentage of patients with at least one episode of atrial arrythmia(AA)
Time frame: between the 3-months and 6-months follow-up visits
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Derived from this study: PubMed 39222035Hauguel-Moreau M, Guedeney P, Dauphin C, Auffret V, Clerc JM, Marijon E, Elbaz M, Aldebert P, Beygui F, Abi Khalil W, Da Costa A, Macia JC, Elhadad S, Cayla G, Iriart X, Laredo M, Rolland T, Temmar Y, Gheorghiu ME, Brugier D, Silvain J, Hammoudi N, Duthoit G, Diallo A, Vicaut E, Montalescot G; ACTION Study Group. Flecainide to Prevent Atrial Arrhythmia After Patent Foramen Ovale Closure: AFLOAT Study, A Randomized Clinical Trial. Circulation. 2024 Nov 19;150(21):1659-1668. doi: 10.1161/CIRCULATIONAHA.124.071186. Epub 2024 Sep 2.
- Derived from this study: PubMed 38216511Hauguel-Moreau M, Guedeney P, Dauphin C, Auffret V, Marijon E, Aldebert P, Clerc JM, Beygui F, Elbaz M, Khalil WA, Da Costa A, Macia JC, Elhadad S, Cayla G, Brugier D, Silvain J, Hammoudi N, Duthoit G, Vicaut E, Montalescot G; ACTION Study Group. Flecainide to prevent atrial arrhythmia after patent foramen ovale closure, Rationale and design of the randomized AFLOAT study. Eur Heart J Cardiovasc Pharmacother. 2024 May 4;10(3):184-189. doi: 10.1093/ehjcvp/pvad100.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giles MONTALESCOT, MD,PhD study chair
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Flecainide in people with Patent Foramen Ovale and Atrial Arrhythmia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of patients with at least one episode of atrial arrythmia (time frame: within 3 months after PFO closure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05213104, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.