IRB Number:

270-05

Trial Status:

Open for Enrollment

Phase: II

Why is this study being done?

This study is being done to find out what effects the WATCHMAN Left Atrial Appendage System has on you and your heart and to assess the safety and effectiveness of the device compared to patients who receive blood thinning medication called warfarin (or Coumadin).

This trial is a randomized trial in which participants will be put into one of two groups by chance (as in the flip of a coin). One group will receive standard medical therapy that involves the use of the blood-thinning medication called warfarin (Coumadin). The other group will have an investigational device called the WATCHMAN Left Atrial Appendage device permanently implanted in their heart.

Who is Eligible to Participate in the Study?

Participants are those who have documented atrial fibrillation and who are able to take blood thinning medication.

Minimum Age:

18

Maximum Age:

101

What is Involved With this Study?

Prior to enrollment, participants would need to have a transesophageal echocardiogram (TEE) and a transthoracic echocardiogram (TTE) to assess the heart.
Regardless of of the study group the participant is assigned to, there are follow-up office exams at 45 days, 6 months, and yearly (for five years).

How long will the Study run?

The length of the study is 5 years.

Who can I Contact for Additional Information on this Trial?

Rebecca Fountain, RN (Study Coordinator)
507-255-4502
Pager: 127-05501

What is/are the Locations of this Clinical Trial?

• Rochester, MN

Last updated: 04/10/2009