Atrial Fibrillation Clinical Trial
— WASPOfficial title:
Registry on WATCHMAN Outcomes in Real-Life Utilization WASP Registry
NCT number | NCT01972295 |
Other study ID # | 90879496 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 13, 2014 |
Est. completion date | March 31, 2019 |
Verified date | June 2017 |
Source | Boston Scientific Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 201 |
Est. completion date | March 31, 2019 |
Est. primary completion date | January 23, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients who are eligible for a WATCHMAN device according to current international and local guidelines (and future revisions) and per physician discretion; - Patients who are willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center; - Patients whose age is 18 years or above, or of legal age to give informed consent specific to state and national law. Exclusion Criteria: - Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility. - Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion); - The subject is unable or not willing to complete follow-up visits and examination for the duration of the study. |
Country | Name | City | State |
---|---|---|---|
Australia | Royal Adelaide Hospital | Adelaide | |
Australia | Greenslopes | Brisbane | |
Australia | Monash Medical | Melbourne | |
Hong Kong | Queen Elizabeth Hospital | Hong Kong | |
Indonesia | Medistra Hospital | Jakarta | |
Korea, Republic of | Severance Hospital | Seoul | |
Malaysia | Institut Jantung Negara | Kuala Lumpur | |
Saudi Arabia | Prince Sultan Cardiac Center | Riyadh | |
Thailand | Ramathibodi Hospital | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Boston Scientific Corporation |
Australia, Hong Kong, Indonesia, Korea, Republic of, Malaysia, Saudi Arabia, Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Procedural complications, Stroke and Death | Descriptive statistics will be used for baseline, procedure and follow-up data collected through the study. | at implant and 2 year follow up |
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