Patent Foramen Ovale Clinical Trials
Cedars-Sinai Heart Institute is currently conducting the following heart valve clinical trials:
The Study Comparing Implant Closure of a Heart Defect called Patent Foramen Ovale (PFO) to Traditional Medical Therapy, “CLOSURE I”
Co-Investigator: Saibal Kar, MD
Principal Investigators: Ravinder Singh, MD
IRB Approval Number: 4133
Contact: Simmy Shirazi (310) 248-6673
Summary: The purpose of the study is to compare the investigational defect closure device (StarFlex) to conventional medical treatment in preventing Stroke or TIA (transient ischemic attack), associated with a heart defect called PFO. The study population includes patients who experienced an index event Stroke or TIA in the previous 6 months, and also have had evidence (by echocardiography) of a PFO. The primary objective is to determine whether the study device will safely and effectively prevent a recurrent embolic Stroke / TIA and to compare these with that of the best medical treatment (aspirin and the blood thinner: warfarin).