Stroke Clinical Trial
— PFO-HUGOfficial title:
Prospective Clinical Follow-up of Patients Presenting With Cryptogenic Stroke Treated With the Percutaneous Closure of a Patent Foramen Ovale
NCT number | NCT01149447 |
Other study ID # | PFO-HUG-Study |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | June 22, 2010 |
Last updated | August 15, 2012 |
Start date | January 2001 |
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, ....).
Status | Recruiting |
Enrollment | 200 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Switzerland | University of Geneva | Geneva | GE |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Geneva |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | residual shunt at 6-12 months follow-up | incidence and clinical relevance of right to left residual shunts at 6-12 months after the successful closure of the PFO | 6-12 months | No |
Primary | stroke recurrence | incidence and clinical predictors of stroke recurrence at 6-12 months | 6-12 months | Yes |
Primary | possible other aetiologies of the initial cryptogenic stroke | during the 12 months follow-up all other possible aetiologies explaining the initial cryptogenic stroke will be taken into consideration | 6-12 months | No |
Secondary | 6 months dual antiplatelet regimen safety and efficacy | confirm the safety and efficacy of the adopted 6 months dual antiplatelet regimen | 6 months | Yes |
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