Patients With Atrial Fibrillation at Risk for Thrombus Formation, Thromboembolism, Stroke Clinical Trial
Official title:
Registry on WATCHMAN Outcomes in Real-Life Utilization
The WATCHMAN LAA Closure Technology is designed to prevent embolization of thrombi that may form in the LAA, thereby preventing the occurrence of ischemic stroke and systemic thromboembolism. The objectives of this observational, prospective, non-randomized multicenter study are (1) to compile real-world clinical outcomes data for WATCHMAN LAA (left atrial appendage) Close Technology in patients who are implanted with the WATCHMAN device in a commercial clinical setting and (2) to collect real-world usage data that may be needed for reimbursement of WATCHMAN technology in certain countries.
Approximately 1000 subjects will be enrolled in the study. To reduce the impact of individual
center bias, each site may include up to 45 subjects and each country may include a maximum
of 500 patients. Up to 70 sites (international, outside of US) will participate in the study.
Primary analyses may include, but will not be limited to, the following: procedural
complications, incidence of stroke and death. Descriptive statistics will be used for
baseline, procedure and follow-up data collected through the study.
Each patient will be followed for a period of two years after enrollment according to the
schedule and standard practice at the enrolling centers. There will be no additional visits,
nor procedures, for subjects who participate in the study. Subjects are expected to be
followed at implant, then at one post-implant visit (typically between 1-3 months of
implant), and then annually through 2 years post implant. An intermediate visit may be
scheduled in a number of patients, per physician discretion. In order to reliably capture
patient status at study end, a follow-up window of 24 +/- 3 months will be considered
acceptable for scheduling the last visit.
For subjects who are not scheduled to visit the clinic for a follow-up, a subject contact
(e.g. phone call) will ensure capture of the endpoint related information; however, it is
recommended to perform an in-office visit for at least the first annual visit.
Enrollment is expected to be completed in 21 months; therefore, the total study duration is
estimated to be 48 months.
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