NCT02533752

Canadian WATCHMAN Registry

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Cardiology Research UBC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation

Timeline

• Start date: 2014-09-01
• Primary completion: 2020-09-01
• Completion: 2020-09-01
• First posted: 2015-08-27
• Last updated: 2018-08-10

Locations

1 site across 1 country: Canada