NCT01149447

Prospective Clinical Follow-up After the Percutaneous Closure of a Patent Foramen Ovale

Prospective Clinical Follow-up of Patients Presenting With Cryptogenic Stroke Treated With the Percutaneous Closure of a Patent Foramen Ovale

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: University Hospital, Geneva · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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, ....).

Detailed 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

Conditions

• Stroke
• Foramen Ovale, Patent

Timeline

• Start date: 2001-01-01
• First posted: 2010-06-23
• Last updated: 2012-08-16

Locations

1 site across 1 country: Switzerland