Interest of Occlusion of Permeable Foramen Ovale After a Cryptogenic Cerebrovascular Accident (CVA) (FOPasa)
|ClinicalTrials.gov Identifier: NCT00872443|
Recruitment Status : Completed
First Posted : March 31, 2009
Last Update Posted : April 28, 2010
Facing the lack of recommandations of Neurology and cardiology societies, the investigators decided in 2002 some Good Medical Practices to define a specific and precise population for whom the closure of permeable oval formaen after a first CVA seem to be necessary. Current survey of these patients after implantation of a prothesis in interauricular septum is defined by a consultation at 1, 3 and 6 months after surgery for a clinical exam and an echocardiography. One year after implantation, the investigators systematically realized a control by MRI associated to a contrast echography.
In the aim of evaluating the investigators' medical practice, the investigators decided to do an observational study which will permit us to judge of the interest or lack of interest of our "Good medical practice" before the publication of prospective and randomised clinical studies.
|Condition or disease||Intervention/treatment|
|Permeable Foramen Ovale Cerebrovascular Accident||Other: Data collection|
|Study Type :||Observational|
|Actual Enrollment :||72 participants|
|Official Title:||Interest of Occlusion of Permeable Foramen Ovale After a Cryptogenic Cerebrovacular Accident.|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||April 2010|
Patients who already have an occlusion of POF secondary to a cryptogenic CVA and younger than 55 years old and without characterized thromboembolic events.
Other: Data collection
Collection of characteristics of interauricular septum, characteristics of the CVA, and headache history.
Collection of anamnesis data, surgical past history, especially at the moment of the implement of prothesis, collection of dtat of transthoracic echography, transcranial echodoppler, holter ECG, cerebral MRI.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00872443
|Nantes University Hospital|
|Nantes, France, 44093|