Atrial Fibrillation, Patent Foramen Ovale, Stroke
Conditions
Brief 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.
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.
Interventions
DEVICEImplantation of Holter device
Implantation of a Holter device (Reveal Linq, Medtronic) for telemonitoring of cardiac rhythm
PROCEDUREPercutaneous PFO closure
Patients will undergo percutaneous closure of patent foramen ovale
Sponsors
Centre Hospitalier Universitaire de Besancon
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Atrial fibrillation | Within 2 months after percutaneous PFO closure | Occurrence of documented atrial fibrillation (i.e. at least one episode lasting 30 seconds) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Burden of atrial fibrillation | Within 2 years after percutaneous PFO closure | Cumulative total time in atrial fibrillation (in days, hours, minutes) |
| Relation between MR proANP levels and atrial fibrillation | Within 2 years after percutaneous PFO closure | Relation between pre-procedure circulating venous MR proANP levels and atrial fibrillation defined as per the primary endpoint |
| Atrial fibrillation | Within 24 months after percutaneous PFO closure | Occurrence of documented atrial fibrillation (i.e. at least one episode lasting 30 seconds) |
| Peripheral emboli | Within 2 years after percutaneous PFO closure | Peripheral emboli by CT or MRI |
| Bleeding | Within 2 years after percutaneous PFO closure | Major or minor bleeding according to the ISTH classification |
| Stroke | Within 2 years after percutaneous PFO closure | Ischemic or hemorrhagic stroke documented by CT or MRI |
Countries
France
Outcome results
None listed