Registry on WATCHMAN Outcomes in Real-Life Utilization WASP Registry — WASP  

Atrial Fibrillation Clinical Trial

Official title: Registry on WATCHMAN Outcomes in Real-Life Utilization WASP Registry

Status Completed

Clinical Trial Summary

This is an observational, prospective, non-randomized, multicenter study with the following objectives: (1) to compile real-world clinical outcomes data for WATCHMAN Left Atrial Appendage Closure Technology in patients who are implanted with the WATCHMAN device in a commercial clinical setting and (2) to collect health care usage data that may be needed for reimbursement of WATCHMAN technology in certain countries.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Atrial Fibrillation

• NCT number: NCT01972295
• Study type: Observational [Patient Registry]
• Source: Boston Scientific Corporation
• Status: Completed
• Start date: January 13, 2014
• Completion date: March 31, 2019