Registry on WATCHMAN Outcomes in Real-Life Utilization (EWOLUTION)
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.
Patients With Atrial Fibrillation at Risk for Thrombus Formation, Thromboembolism, Stroke
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration:||2 Years|
|Official Title:||Registry on WATCHMAN Outcomes in Real-Life Utilization|
- Procedural complications [ Time Frame: At Implant ] [ Designated as safety issue: Yes ]
- Stroke [ Time Frame: 2 year follow-up ] [ Designated as safety issue: Yes ]
- Death [ Time Frame: 2 year follow-up ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2013|
|Estimated Study Completion Date:||November 2017|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01972282
|Contact: Elke Sommerijnsfirstname.lastname@example.org|
|Contact: Kirsten Welz||+49 2429 email@example.com|
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