This study is evaluating a new device called CLAAS for people with atrial fibrillation (an irregular heartbeat) who are at high risk of stroke. The goal is to see if the CLAAS device is as safe and effective as two currently available devices, WATCHMAN and Amulet, in preventing strokes. You might be able to join if you are 18 or older, have non-valvular atrial fibrillation, a high risk of stroke (CHA2DS2-VASc score of 3 or higher), and your doctor believes a non-medication option is best for you. Participants will be randomly assigned to receive either the CLAAS device or one of the other two devices. The study will look at complications, death, and major bleeding at 12 months, and strokes and blood clots at 18 months. The study status is currently unclear.

Study design

This is an interventional study planning to enroll 1600 participants. Participants will be randomly assigned to receive one of the study devices.

What's involved

Participants will receive a device implant and be followed for 5 years after the implant.

Compensation

Not stated in the trial record.

Follow-up

Participants will be followed for 5 years after the device implant. Primary outcomes are measured at 12 and 18 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.