Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01972295




Registration number
NCT01972295
Ethics application status
Date submitted
24/10/2013
Date registered
30/10/2013
Date last updated
21/08/2019

Titles & IDs
Public title
Registry on WATCHMAN Outcomes in Real-Life Utilization WASP Registry
Scientific title
Registry on WATCHMAN Outcomes in Real-Life Utilization WASP Registry
Secondary ID [1] 0 0
90879496
Universal Trial Number (UTN)
Trial acronym
WASP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Procedural complications, Stroke and Death
Timepoint [1] 0 0
at implant and 2 year follow up

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/01/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/03/2019
Sample size
Target
Accrual to date
Final
201
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Greenslopes - Brisbane
Recruitment hospital [3] 0 0
Monash Medical - Melbourne
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Hong Kong
State/province [1] 0 0
Hong Kong
Country [2] 0 0
Indonesia
State/province [2] 0 0
Jakarta
Country [3] 0 0
Korea, Republic of
State/province [3] 0 0
Seoul
Country [4] 0 0
Malaysia
State/province [4] 0 0
Kuala Lumpur
Country [5] 0 0
Saudi Arabia
State/province [5] 0 0
Riyadh
Country [6] 0 0
Thailand
State/province [6] 0 0
Bangkok

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01972295
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lynnett Voshage-Stahl
Address 0 0
Boston Scientific Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01972295