Atrial Fibrillation
Conditions
Keywords
Left Atrial Appendage Closure, Watchman device, LAA Closure
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.
Interventions
None listed
Sponsors
Cardiology Research UBC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Events | From up to 24 Months from procedure | Composite: Cardiovascular death (or unexplained death), device embolization, stroke, systemic embolism, myocardial infarction, cardiac tamponade, major bleeding, and the need for cardiovascular surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Long-term Events | From hospital discharge to 24 Months | Composite: Overall mortality, cardiovascular mortality, ischemic and hemorrhagic stroke, systemic embolization, late device embolization (beyond hospitalization) |
| Procedural Technical Success | Procedural (up to the end of procedure) | Procedure duration and complications |
| Procedural complications | Procedural (up to hospital discharge) | 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 |
Other
| Measure | Time frame |
|---|---|
| Prevalence and severity of residual leak | up to 3 Months from procedure |
| Prevalence of device thrombus | up to 3 Months from procedure |
| Ability to switch to single antiplatelet therapy | up to 3 Months from procedure |
Countries
Canada
Contacts
Primary ContactJacqueline Saw, MD
Backup ContactAndrew Starovoytov, MD
Outcome results
None listed