Protect Atrial Fibrillation Study

Study Summary

The Cardiology Section at the University of Chicago is conducting a clinical trial to test an experimental device aimed at reducing stroke in patients with atrial fibrillation (AF). Standard treatment for patients with AF is long term anti-coagulation therapy with warfarin (Coumadin®), a blood thinning drug. The purpose of this research study is to determine whether a new experimental device can be safely implanted, and to evaluate the safety and effectiveness of the device compared to patients who receive the blood thinning medication called warfarin (or Coumadin).

There may be no personal benefit to the subject for participating. It is not known at the present time if this device is more effective at reducing stroke than standard therapy. Subjects who receive the experimental device may be able to stop taking Coumadin® and no longer need to have blood drawn for dose adjustments

Participation Details

Initial selection criteria:

• Must have atrial fibrillation
• Must currently be taking warfarin (Coumadin®)

Participants will be randomly assigned (like flipping a coin) to either receive the device or continue on standard medical therapy which is long term Coumadin®. Participants will make approximately four to five visits to the medical center during the first 12 months of the study.

Study Directors: John Lopez, MD and Bradley Knight, MD
Department: Department of Medicine, Section of Cardiology

For more information, please contact:
Charity Ball, RN
(773) 834-8399

IRB: #13791A