Prospective Clinical Follow-up After the Percutaneous Closure of a Patent Foramen Ovale (PFO-HUG)

University Hospitals (UH)

Status: Unknown

Conditions: Foramen Ovale, Patent; Stroke

Study type: Observational

Funder types: Other

Identifiers

NCT01149447

PFO-HUG-Study

Details and patient eligibility

About

Following a cryptogenic stroke, many patients are nowadays treated with the percutaneous closure of a patent foramen ovale (PFO), assuming that the aetiology of the stroke is secondary to a paradoxical embolism. After the PFO closure procedure a dual antiplatelet regimen is often prescribed for 3-6 months and several cardiologic and neurologic follow-up exams are scheduled in the first 12 months of follow-up. Usually a transthoracic +/- transoesophageal echocardiography (TTE +/- TEE) are performed at 6 months, however this kind of control is not systematically performed. In order to improve the clinical outcomes in this young patients' population, the investigators prospectively perform a complete cardiologic and neurologic follow-up program to all patients undergoing a successful percutaneous closure of a PFO.

The aim of these controls is to confirm the good position of the PFO-device, to confirm the absence of any residual right to left shunt or any significant atrial arrhythmias Furthermore this prospective follow-up will analyze the possible mechanisms leading to a cerebral stroke recurrence (e.g. size of the PFO, presence of an atrial septal aneurysm, presence of a residual shunt, size of the utilized closure device, ....).

Full description

At follow-up the following exams will be performed:

• at hospital discharge: chest X-ray +/- TTE + 7-days event loop record (ELR)
• at 6 months: clinical cardiologic and neurologic examination + TTE + TEE + 7-days ELR + trans-cranial doppler (TCD) with micro bubbles detection.
• at 1 year: clinical cardiologic and neurologic examination + TTE +/- TEE + 7-days ELR + trans-cranial doppler (TCD) with micro bubbles detection +/- cerebral MRI

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years old patients
• signed informed consent
• all consecutive patients undergoing a successful percutaneous closure of a PFO secondary to a cryptogenic stroke

Exclusion criteria

• all patients with an alternative aetiology of the initial stroke
• all patients in whom the percutaneous closure of the PFO is contraindicated
• all patients with a known allergy to aspirin and or clopidogrel