Registry on WATCHMAN Outcomes in Real-Life Utilization WASP Registry (WASP)
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|ClinicalTrials.gov Identifier: NCT01972295|
Recruitment Status : Completed
First Posted : October 30, 2013
Last Update Posted : August 21, 2019
|Condition or disease|
Approximately 200 subjects will be enrolled in the study. Up to 10 sites in the Asia Pacific and Middle East regions will participate.
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 implant 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 clinical 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 :||201 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||Registry on WATCHMAN Outcomes in Real-Life Utilization WASP Registry|
|Actual Study Start Date :||January 13, 2014|
|Actual Primary Completion Date :||January 23, 2018|
|Actual Study Completion Date :||March 31, 2019|
- Procedural complications, Stroke and Death [ Time Frame: at implant and 2 year follow up ]Descriptive statistics will be used for baseline, procedure and follow-up data collected through the study.
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): NCT01972295
|Royal Adelaide Hospital|
|Queen Elizabeth Hospital|
|Hong Kong, Hong Kong|
|Korea, Republic of|
|Seoul, Korea, Republic of|
|Institut Jantung Negara|
|Kuala Lumpur, Malaysia|
|Prince Sultan Cardiac Center|
|Riyadh, Saudi Arabia|
|Study Director:||Lynnett Voshage-Stahl||Boston Scientific Corporation|