Ignite Creation Date:
2024-05-06 @ 7:25 AM
Last Modification Date:
2024-10-26 @ 11:48 AM
Study NCT ID:
NCT02533752
Status:
UNKNOWN
Last Update Posted:
2018-08-10
First Post:
2015-03-24
Brief Title:
Canadian WATCHMAN Registry
Sponsor:
Cardiology Research UBC
Organization:
Cardiology Research UBC
Study Overview
Official Title:
Canadian WATCHMAN Registry
Status:
UNKNOWN
Status Verified Date:
2018-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WATCHMAN
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 15-2 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None