Registry on WATCHMAN Outcomes in Real-Life Utilization WASP Registry (WASP)

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.

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 201

Contacts and Locations

Study Locations

• Australia
  • Adelaide, Australia
    • Royal Adelaide Hospital
  • Brisbane, Australia
    • Greenslopes
  • Melbourne, Australia
    • Monash Medical
• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Elizabeth Hospital
• Indonesia
  • Jakarta, Indonesia
    • Medistra Hospital
• Korea, Republic of
  • Seoul, Korea, Republic of
    • Severance Hospital
• Malaysia
  • Kuala Lumpur, Malaysia
    • Institut Jantung Negara
• Saudi Arabia
  • Riyadh, Saudi Arabia
    • Prince Sultan Cardiac Center
• Thailand
  • Bangkok, Thailand
    • Ramathibodi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with non-valvular atrial fibrillation

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Study Director: Lynnett Voshage-Stahl, Boston Scientific Corporation

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 13, 2014
• Primary Completion (ACTUAL): January 23, 2018
• Study Completion (ACTUAL): March 31, 2019

Study Registration Dates

• First Submitted: October 24, 2013
• First Submitted That Met QC Criteria: October 24, 2013
• First Posted (ESTIMATE): October 30, 2013

Study Record Updates

• Last Update Posted (ACTUAL): August 21, 2019
• Last Update Submitted That Met QC Criteria: August 20, 2019
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 90879496

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED