Canadian WATCHMAN Registry

Study Overview
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Brief Summary
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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
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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.

Official Title
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Canadian WATCHMAN Registry

Conditions
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Atrial Fibrillation

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Main Group<br>This an observational registry - there is only one group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Events | Composite: Cardiovascular death (or unexplained death), device embolization, stroke, systemic embolism, myocardial infarction, cardiac tamponade, major bleeding, and the need for cardiovascular surgery | From up to 24 Months from procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term Events | Composite: Overall mortality, cardiovascular mortality, ischemic and hemorrhagic stroke, systemic embolization, late device embolization (beyond hospitalization) | From hospital discharge to 24 Months | 
| Procedural Technical Success | Procedure duration and complications | Procedural (up to the end of procedure) | 
| Procedural complications | Stroke (ischemic and hemorrhagic), air embolism, pericardial effusion (minor - not requiring intervention; serious - requiring percutaneous or surgical drainage), cardiac perforation, device embolization, major or life-threatening/disabling bleeding | Procedural (up to hospital discharge) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Left Atrial Appendage Closure, Watchman device, LAA Closure