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

Recruiting

Phase N/A Results N/A

Trial Description

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

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial Population

all consecutive patients presenting with a cryptogenic stroke, in whom a successful percutaneous closure of their PFO is performed

Outcomes

Type Measure Time Frame Safety Issue
Primary residual shunt at 6-12 months follow-up 6-12 months No
Primary stroke recurrence 6-12 months Yes
Primary possible other aetiologies of the initial cryptogenic stroke 6-12 months No
Secondary 6 months dual antiplatelet regimen safety and efficacy 6 months Yes

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