Assessment of the WATCHMAN Device in Patients Unsuitable for Oral Anticoagulation (ASAP-TOO)
Brief description of study
This study involves implantation of the WATCHMAN™ Device without the use of OAC therapy. This study is targeted to patients who are deemed not eligible for OAC therapy. The implantation of the WATCHMAN™ Device is deemed investigational because the WATCHMAN™ Device has not been approved by the FDA for use without short-term OAC therapy. In this study, the WATCHMAN™ Device and implantation procedure is the same as the FDA approved WATCHMAN™ Device. The only experimental difference is that no OAC therapy will be administered after implant of the WATCHMAN™ Device. This study will evaluate the safety and effectiveness of the WATCHMAN™ Device in patients who cannot use OAC therapy.
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