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

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Observational

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

Brief 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 Summary:

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

Sponsor: University Hospital, Geneva

Current Primary Outcome:

  • residual shunt at 6-12 months follow-up [ Time Frame: 6-12 months ]
    incidence and clinical relevance of right to left residual shunts at 6-12 months after the successful closure of the PFO
  • stroke recurrence [ Time Frame: 6-12 months ]
    incidence and clinical predictors of stroke recurrence at 6-12 months
  • possible other aetiologies of the initial cryptogenic stroke [ Time Frame: 6-12 months ]
    during the 12 months follow-up all other possible aetiologies explaining the initial cryptogenic stroke will be taken into consideration


Original Primary Outcome: Same as current

Current Secondary Outcome: 6 months dual antiplatelet regimen safety and efficacy [ Time Frame: 6 months ]

confirm the safety and efficacy of the adopted 6 months dual antiplatelet regimen


Original Secondary Outcome: Same as current

Information By: University Hospital, Geneva

Dates:
Date Received: June 22, 2010
Date Started: January 2001
Date Completion:
Last Updated: August 15, 2012
Last Verified: August 2011