Registry on WATCHMAN Outcomes in Real-Life Utilization (EWOLUTION)
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|ClinicalTrials.gov Identifier: NCT01972282|
Recruitment Status : Unknown
Verified January 2016 by Boston Scientific Corporation.
Recruitment status was: Active, not recruiting
First Posted : October 30, 2013
Last Update Posted : January 12, 2016
|Condition or disease|
|Patients With Atrial Fibrillation at Risk for Thrombus Formation, Thromboembolism, Stroke|
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.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||1021 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||Registry on WATCHMAN Outcomes in Real-Life Utilization|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||November 2015|
|Estimated Study Completion Date :||November 2017|
- Procedural complications [ Time Frame: At Implant ]
- Stroke [ Time Frame: 2 year follow-up ]
- Death [ Time Frame: 2 year follow-up ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01972282
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