Prospective Clinical Follow-up After the Percutaneous Closure of a Patent Foramen Ovale (PFO-HUG)
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|ClinicalTrials.gov Identifier: NCT01149447|
Recruitment Status : Unknown
Verified August 2011 by Robert F Bonvini, University Hospital, Geneva.
Recruitment status was: Recruiting
First Posted : June 23, 2010
Last Update Posted : August 16, 2012
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, ....).
|Condition or disease|
|Stroke Foramen Ovale, Patent|
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
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Prospective Clinical Follow-up of Patients Presenting With Cryptogenic Stroke Treated With the Percutaneous Closure of a Patent Foramen Ovale|
|Study Start Date :||January 2001|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01149447
|Contact: Robert F Bonvini, MDemail@example.com|
|University of Geneva||Recruiting|
|Geneva, GE, Switzerland, 1211|
|Contact: Robert F Bonvini, MD 0041223727200 firstname.lastname@example.org|
|Principal Investigator:||Robert F Bonvini, MD||University of Geneva|