Registry on WATCHMAN Outcomes in Real-Life Utilization (EWOLUTION)
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|ClinicalTrials.gov Identifier: NCT01972282|
Recruitment Status : Completed
First Posted : October 30, 2013
Results First Posted : May 7, 2019
Last Update Posted : May 7, 2019
|Condition or disease||Intervention/treatment|
|Patients With Atrial Fibrillation at Risk for Thrombus Formation, Thromboembolism, Stroke||Device: WATCHMAN Left Atrial Appendage Closure|
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 :||1025 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||Registry on WATCHMAN Outcomes in Real-Life Utilization|
|Actual Study Start Date :||October 28, 2013|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||January 4, 2018|
- Procedural Complications [ Time Frame: 7 days post-implant ]All device/procedure related Serious Adverse Events (with or without Major intervention)
- Ischemic Stroke [ Time Frame: 2 year follow-up ]occurence of Ischemic stroke during the 2 years of FU. Expressed as nr events / 100 patient-years of FU
- Death [ Time Frame: 2 year follow-up ]All cause mortality
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
|Principal Investigator:||Lucas VA Boersma||St. Antonius Ziekenhuis Nieuwegein, The Netherlands|