Clinical trial NCT02533752: Canadian WATCHMAN Registry
Official title: Canadian WATCHMAN Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Keywords: Left Atrial Appendage Closure
Watchman device
LAA Closure
Lead sponsor: Cardiology Research UBC
Sponsor class: OTHER
First posted: 2015-08-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing WATCHMAN device Implantation

Brief summary: Canadian WATCHMAN Registry is a multicentre (8 Centres) Canadian prospective, non-randomized, registry to enrol 100 consecutive patients undergoing LAA closure with the WATCHAN device to study the safety and effectiveness of the WATCHMAN device

Detailed description: Atrial fibrillation (AF) is the most common cardiac arrhythmia with current prevalence estimated at 1.5-2% of the general population. AF is a major cause of stroke, responsible for 15% of all strokes and 30% of strokes in patients age \>80. Stroke is the leading cause of long-term disability and is the 4th leading cause of death in the US. Anticoagulation is the mainstay therapy for preventing strokes in AF with a 64% relative stroke reduction and 26% relative mortality benefit with warfarin therapy. Warfarin or newer anticoagulation treatments (NOAC) have been associated with increased risk of major bleeding and therefore a significant proportion (30-50%) of eligible patients do not receive therapy due to perceived risk of bleeding. The need for newer therapy is therefore required and percutaneous left atrial appendage closure (LAAC) devices have been investigated for patients with high risk of stroke and contra-indication to long term oral anticoagulation therapy. The WATCHMAN device is one of the leading LAA closure devices and with the most world-wide clinical experience. The investigators are running a multicentre (8 Centres) Canadian prospective, non-randomized, registry to enrol 100 consecutive patients undergoing LAA closure with the WATCHAN device to study the safety and effectiveness of the WATCHMAN device.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years, and
* CHADS2 ≥1 and/or CHADS-VASc ≥2, and
* Prior major bleeding (intracranial, gastrointestinal bleeding, intraocular, respiratory, genitourinary, retroperitoneal, pericardial, anemia requiring transfusions, etc.), or contraindications to long-term OAC (HASBLED ≥3, high fall risk, cerebral aneurysm, blood dyscrasias, aortic dissection, etc.), or failure of OAC (stroke/TIA while on OAC)

Exclusion Criteria:

* Presence of LAA thrombus
* Severe untreated mitral stenosis (no prior valve replacement)

Primary outcomes:
measure: Major Adverse Events
timeFrame: From up to 24 Months from procedure
Secondary outcomes:
measure: Long-term Events
timeFrame: From hospital discharge to 24 Months
measure: Procedural Technical Success
timeFrame: Procedural (up to the end of procedure)
measure: Procedural complications
timeFrame: Procedural (up to hospital discharge)
Other outcomes:
measure: Ability to switch to single antiplatelet therapy
timeFrame: up to 3 Months from procedure
measure: Prevalence and severity of residual leak
timeFrame: up to 3 Months from procedure
measure: Prevalence of device thrombus
timeFrame: up to 3 Months from procedure
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Jacqueline Saw, MD
role: PRINCIPAL_INVESTIGATOR
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