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The primary objective is to evaluate if patent foramen ovale (PFO) closure and antiplatelet medical management can reduce the risk of recurrent stroke or transient ischemic attack (TIA) when compared to antiplatelet medical management alone in elderly patients above 50 years of age with a PFO and a history of cryptogenic stroke or TIA.
Prior to birth the fetal heart has a connection between the two atrias of the heart. After labour this connection often closes. About 10-15 % these connections remains open. This phenomenon is called patent foramen ovale or PFO, and is in most cases unsymptomatic.
The prevalence of PFO in patients with crytogenic (without known causes) stroke is much higher (about 40%)than the general population (about 10%). This has led to the theory that the presence of PFO can lead to stroke, by the passage of emboli from the peripheral venous circulation through the PFO to the brain by right-to-left shunting of the blood.
There are no existing data from prospective randomized studies focusing on the effect of device closure PFO in patients with cryptogenic stroke. Some observational retrospective studies have shown a beneficial effect in the reduction of recurrent stoke in patients younger that 50 years with cryptogenic stroke when PFO has been closed with a percutaneous device closure(PCD). Some studies have reported an 0% to 3.4% annual recurrence rate of stroke or TIA in patients treated with PDC. The recurrence rate of stroke or TIA in patients with crytogenic stroke or TIA in ordinary antithrombotic treatment is about 5-15 %.
The primary objective of this study is to assess whether percutaneous device closure of patent foramen ovale is superior to conventional antithrombotic treatment in preventing stroke recurrence in elderly patients above 50 years of age.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Patent Foramen Ovale
Percutaneous device closure of patent foramen ovale
Dept. of cardiology and endocrinology H
Hillerod Hospital, Denmark
Published on BioPortfolio: 2014-08-27T03:17:49-0400
Closure of Patent Foramen Ovale with the AMPLATZER® PFO OCCLUDER in patients with at least two cryptogenic strokes due to presumed paradoxical embolism through a patent foramen ovale and ...
The foramen ovale is an opening in the interatrial septum. It results from an incomplete coverage of the ostium secundum. In 10 to 24% of the general population incomplete fibrosis of the ...
The purpose of this study is to compare two treatments strategies to prevent further attacks in patients who have suffered an stroke or occlusion of a major artery with no obvious reason o...
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The purpose of this study is to evaluate migraine headache frequency in subjects who have migraine with aura and a patent foramen ovale (PFO, a slit-like opening between the right and left...
: The migration of a percutaneous patent foramen ovale closure device is a very rare but serious complication. Late or very late embolization of device requires a different management strategy due to ...
We aimed to analyze whether patent foramen ovale (PFO) closure reduces the risk of stroke, assessing also some safety outcomes after the publication of a new trial.
Recent randomized control trials (RCTs) have suggested benefit with transcatheter patent foramen ovale (PFO) closure plus antiplatelet therapy over medical treatment alone for secondary stroke prevent...
The clinical benefit of patent foramen ovale (PFO) closure in patients with cryptogenic stroke (CS) for recurrent stroke prevention has been a subject of extensive debate. Prior clinical trials failed...
A condition in which the FORAMEN OVALE in the ATRIAL SEPTUM fails to close shortly after birth. This results in abnormal communications between the two upper chambers of the heart. An isolated patent ovale foramen without other structural heart defects is usually of no hemodynamic significance.
A syndrome of persistent PULMONARY HYPERTENSION in the newborn infant (INFANT, NEWBORN) without demonstrable HEART DISEASES. This neonatal condition can be caused by severe pulmonary vasoconstriction (reactive type), hypertrophy of pulmonary arterial muscle (hypertrophic type), or abnormally developed pulmonary arterioles (hypoplastic type). The newborn patient exhibits CYANOSIS and ACIDOSIS due to the persistence of fetal circulatory pattern of right-to-left shunting of blood through a patent ductus arteriosus (DUCTUS ARTERIOSUS, PATENT) and at times a patent foramen ovale (FORAMEN OVALE, PATENT).
An opening in the wall between the right and the left upper chambers (HEART ATRIA) of a fetal heart. Oval foramen normally closes soon after birth; when it fails to close the condition is called PATENT OVAL FORAMEN.
The space enclosed by the peritoneum. It is divided into two portions, the greater sac and the lesser sac or omental bursa, which lies behind the STOMACH. The two sacs are connected by the foramen of Winslow, or epiploic foramen.
Blockage of an artery due to passage of a clot (THROMBUS) from a systemic vein to a systemic artery without its passing through the lung which acts as a filter to remove blood clots from entering the arterial circulation. Paradoxical embolism occurs when there is a defect that allows a clot to cross directly from the right to the left side of the heart as in the cases of ATRIAL SEPTAL DEFECTS or open FORAMEN OVALE. Once in the arterial circulation, a clot can travel to the brain, block an artery, and cause a STROKE.
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