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Enrollment Complete on PREVAIL Trial
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The PREVAIL trial, which will compare the Watchman Left Atrial Appendage Closure Device with warfarin in high-risk patients with atrial fibrillation, has completed enrollment, according to a press release.
In the randomized, prospective PREVAIL trial, the Watchman device (Boston Scientific) will be tested in 407 patients at 42 sites. Patients were randomly assigned to either the device or long-term warfarin (Coumadin, Bristol-Myers Squibb) therapy, and those who received the device will remain on warfarin for 45 days following implantation.
Currently, the Watchman device has been tested in more than 2,000 patients for more than 4,000 patient-years of follow-up. This includes the PROTECT AF trial, in which the device was shown to be noninferior to warfarin, and the ASA Plavix (ASAP) trial, which showed a reduction of 77% in the risk for ischemic stroke in patients with AF contraindicated for long-term warfarin therapy who were implanted with the device.
The Watchman device is approved for marketing in Europe and some countries in Asia.