Patent Foramen OvalePFO-AFNCT04926142
Prevalence of Atrial Fibrillation in Cryptogenic Stroke With Patent Foramen Ovale Closure (PFO-AF) Study
An observational study of Patent Foramen Ovale and Atrial Fibrillation, run by Centre Hospitalier Universitaire de Besancon at 4 sites in France.
Trial summary
This study aims to assess the incidence of atrial fibrillation (AF), documented using data recorded by an implantable Holter monitoring device (Reveal Linq, Medtronic) within 2 years after percutaneous closure of patent foramen ovale for cryptogenic stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patent Foramen Ovale, Atrial Fibrillation, Stroke
- What is being tested?
- Implantation of Holter device and Percutaneous PFO closure
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 250 participants
- Where
- 4 sitesFrance
- Study dates
- 5 Jul 2021to 3 Mar 2026
- Phase
- Observational
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
Study population: Prospective patients who have had cryptogenic stroke (ischemic only) and with patent foramen ovale confirmed by transoesophageal echocardiography, with an indication for percutaneous closure.
Who may be able to join
- Adult patients (aged >18 years)
- with an indication for percutaneous closure of PFO due to cryptogenic stroke, with indication validated by a cardio-neurological team.
- patients must provide written informed consent
- patients must be affiliated to a social security regime or be a beneficiary thereof.
Who cannot join
- Patients under legal protection
- Patients not affiliated to any social security regime
- Patients within the exclusion period of another clinical trial as per the national registry of research volunteers
Trial locations and contacts
4 sites in 1 country.
France4 sites
University Hospital Besancon
Besançon, 25000
CHU Lyon - Hôpital Louis Pradel
Bron
CHU Dijon
Dijon
CHU Grenoble
Grenoble
About this study
This study aims to assess the incidence of atrial fibrillation (AF), documented using data recorded by an implantable Holter monitoring device (Reveal Linq, Medtronic) within 2 years after percutaneous closure of patent foramen ovale for cryptogenic stroke.
Read the detailed description
This study aims to assess the incidence of atrial fibrillation (AF), documented using data recorded by an implantable Holter monitoring device (Reveal Linq, Medtronic) within 2 years after percutaneous closure of patent foramen ovale (PFO) for cryptogenic stroke. Secondary objectives include assessment of the burden of AF at 2, 12 and 24 months after PFO closure; evaluation of the relationship between plasma levels of MR proANP and presence of AF within 2 years after percutaneous PFO closure in patients with a history of cryptogenic ischemic stroke; and description of recurrence rates for stroke (ischemic and hemorrhagic), major bleeding, minor bleeding, peripheral emboli during the 2-year follow-up period after percutaneous PFO closure, in patients with and without AF.
- Conditions
- Patent Foramen Ovale, Atrial Fibrillation, Stroke
- Being tested
- Implantation of Holter device, Percutaneous PFO closure
- Medical subject headings
- Foramen Ovale, Patent, Atrial Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of Holter deviceDevice
Implantation of a Holter device (Reveal Linq, Medtronic) for telemonitoring of cardiac rhythm
Percutaneous PFO closureProcedure or surgery
Patients will undergo percutaneous closure of patent foramen ovale
| Study group | Role | What they receive |
|---|---|---|
| Patients planned for percutaneous PFO closure | Patients will undergo implantation of a Holter device (Reveal Linq Medtronic) 2 months prior to percutaneous PFO closure. Devices will be monitored by telemonitoring until the PFO closure procedure, and at 2, 12 and 24 months after the procedure. Receives: Device: Implantation of Holter device; Procedure: Percutaneous PFO closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial fibrillation
Occurrence of documented atrial fibrillation (i.e. at least one episode lasting 30 seconds)
Measured: Within 2 months after percutaneous PFO closure
Secondary outcomes (6)
Atrial fibrillation
Occurrence of documented atrial fibrillation (i.e. at least one episode lasting 30 seconds)
Measured: Within 24 months after percutaneous PFO closure
Burden of atrial fibrillation
Cumulative total time in atrial fibrillation (in days, hours, minutes)
Measured: Within 2 years after percutaneous PFO closure
Relation between MR proANP levels and atrial fibrillation
Relation between pre-procedure circulating venous MR proANP levels and atrial fibrillation defined as per the primary endpoint
Measured: Within 2 years after percutaneous PFO closure
Stroke
Ischemic or hemorrhagic stroke documented by CT or MRI
Measured: Within 2 years after percutaneous PFO closure
Peripheral emboli
Peripheral emboli by CT or MRI
Measured: Within 2 years after percutaneous PFO closure
Bleeding
Major or minor bleeding according to the ISTH classification
Measured: Within 2 years after percutaneous PFO closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start5 Jul 2021
- Primary completion21 Aug 2025
- Study completion3 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patent Foramen OvaleStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Badoz, MD, Principal investigator, Centre Hospitalier Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04926142
- Sponsor's protocol ID
- 2020-A03417-32
- Acronym
- PFO-AF
- Status last verified
- Mar 2026
- First submitted
- 11 Jun 2021
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Badoz M, Derimay F, Serzian G, Besutti M, Rioufol G, Frey P, Guenancia C, Ecarnot F, Meneveau N, Chopard R. Incidence of atrial fibrillation in cryptogenic stroke with patent foramen ovale closure: protocol for the prospective, observational PFO-AF study. BMJ Open. 2023 Sep 12;13(9):e074584. doi: 10.1136/bmjopen-2023-074584.
PubMed 37699623