PFO Closure Device for Preventing Stroke (REDUCE PAS Trial)

"To facilitate this research, 636 participants that fulfill the inclusion criteria are necessary. W.L Gore & Associates will be conducting the trial at multiple sites including Medical Center of the Rockies in Loveland, Colorado and Providence Heart & Vascular Institute in Portland, Oregon."

"According to the prerequisites for this clinical trial, individuals between 18 and 70 years of age are eligible. There is a separate cohort of 39 trials available to minors while those 65 or older can join one of the 1019 other studies."

"Medical Center of the Rockies in Loveland, Colorado, Providence Heart & Vascular Institute in Portland Oregon, and Yale University School of Medicine in New Haven Connecticut are among the 38 sites that are running this experiment."

"According to the source of this trial, W.L.Gore & Associates, the principal outcome which is monitored over a two year period is Proportion of subjects with device- or procedure-related serious adverse events at 30 days (Primary Safety Endpoint). Secondary objectives being assessed include Residual Shunt Characterization via assessment of shunt in patients by Echo as well as Effective PFO Closure defined as complete PFO closure or a trivial or small residual shunt by Echocardiographic assessment and Clinically Significant New Atrial Arrhythmia which refers to any new occurrence of atrial fibrillation or flutter"

"For this study, 636 strokes patients aged between 18 and 70 may be admitted. However, to meet the inclusion criteria of this clinical trial, participants must tolerate antiplatelet therapy; supplementary selection conditions may also apply."

"Indeed, the information accessible on clinicaltrials.gov displays that this medical trial is in progress and enrolling candidates. The study was established onto July 25th 2019 and has been updated just recently June 6th 2022. Altogether, 37 locations are looking for a total of 636 participants to join the experiment."