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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
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

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.

Condition or disease
Atrial Fibrillation

Detailed 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.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 201 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with non-valvular atrial fibrillation
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Australia
Royal Adelaide Hospital
Adelaide, Australia
Greenslopes
Brisbane, Australia
Monash Medical
Melbourne, Australia
Hong Kong
Queen Elizabeth Hospital
Hong Kong, Hong Kong
Indonesia
Medistra Hospital
Jakarta, Indonesia
Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of
Malaysia
Institut Jantung Negara
Kuala Lumpur, Malaysia
Saudi Arabia
Prince Sultan Cardiac Center
Riyadh, Saudi Arabia
Thailand
Ramathibodi Hospital
Bangkok, Thailand
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Study Director: Lynnett Voshage-Stahl Boston Scientific Corporation

Additional Information:

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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01972295     History of Changes
Other Study ID Numbers: 90879496
First Posted: October 30, 2013    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes