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Results of the PC trial presented at TCT 2012
Date:10/25/2012

MIAMI, FL OCTOBER 25, 2012 A clinical trial that compared catheter-based PFO closure using an investigational device found that there was no significant reduction in ischemic and bleeding events compared to standard medical therapy; stroke risk was non-significantly reduced with device therapy. The PC Trial was presented at the 24th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world's premier educational meeting specializing in interventional cardiovascular medicine.

A PFO (patent foramen ovale) is a hole between the left and right upper chambers (atria) of the heart that fails to close just after birth. Approximately one in four people grow up with a PFO. In some cases a blood clot may pass through the PFO and can potentially travel to the brain causing an ischemic stroke. It is estimated that PFO rates are three times higher in the population of patients with cryptogenic stroke, or stroke without an overt source.

The PC Trial compared the efficacy of the percutaneous closure of a PFO using the Amplatzer PFO Occluder with medical treatment in patients with cryptogenic stroke with peripheral embolism. Made of wire mesh, the investigational device is inserted into the PFO through a catheter to seal the passageway between the left and right atria.

Patients were randomized in 29 centers in Europe, Brazil, Canada, and Australia. Enrollment of 414 patients was completed in February 2009. The primary endpoint of the trial was a composite of death from any cause, non-fatal stroke, transient ischemic attack (TIA), and peripheral embolism.

For the primary composite endpoint (death from any cause, non-fatal stroke, TIA, and peripheral embolism) researchers found a relative risk reduction of 37 percent when using the investigational device; this reduction was not statistically significant. Results also indicated no significant redu
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Contact: Judy Romero
jromero@crf.org
Cardiovascular Research Foundation
Source:Eurekalert

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