CARDIA STAR™ Trial: A United States Randomized Clinical Trial of the CARDIA STAR™ Patent Foramen Ovale Closure System (The CARDIA STAR™ Trial)
Study of:
CARDIA STAR™ PFO closure device; sponsored by Cardia, Inc. For more information visit www.cardiainc.com.
The CARDIA STAR™ Trial is a multi-center randomized trial to evaluate the safety and effectiveness of the CARDIA STAR™ PFO closure device. A Patent Foramen Ovale (PFO) is a persistent, slit-like opening between the right and left atrial chambers of the heart. It usually closes shortly after birth, but in a small percentage of people this opening persists. The opening can lead to blood clots, which can cause strokes and other complications. Closing these openings with a device like the CARDIA STAR™ may prevent further neurological complications. A maximum of 50 centers in the United States will participate enrolling a total of 300 patients. All patients must have suffered a prior stroke in order to participate in the trial. Patients will be randomized to one of two treatment groups: (1) those who receive the CARDIA STAR™ device and (2) those who receive 12 months of anticoagulation therapy. The device group will have 3, 6 and 12 month clinic visits. The anticoagulation group will receive phone calls at 3, 6 and 12 months.
For more information about the interventional cardiology research program at the Minneapolis Heart Institute and Minneapolis Heart Institute Foundation, please contact Carol Stone at 612-863-9124. |