Ignite Creation Date:
2025-12-24 @ 7:03 PM
Ignite Modification Date:
2025-12-25 @ 4:37 PM
Study NCT ID:
NCT03014557
Status:
UNKNOWN
Last Update Posted:
2017-01-09
First Post:
2017-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
China REgistry of WATCHMAN
Sponsor:
Fu Wai Hospital, Beijing, China
Organization:
Study Overview
Official Title:
China REgistry of WATCHMAN Left Atrial Appendage Closure for Non-valvular Atrial Fibrillation
Status:
UNKNOWN
Status Verified Date:
2017-01
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:
CREW
Brief Summary:
This registry is designed to observe the safety and effectiveness of WATCHMAN left atrial appendage closure technology in a Chinese population.
Detailed Description:
In this prospective, multi-center, single arm observational study, 413 patients with non-valvular atrial fibrillation intended to be implanted with a WATCHMAN device based on real clinical practice will be enrolled. Enrolled subjects will be followed up for 5 years.Primary endpoints include stroke, systematic embolism, cardiovascular death, and procedure or device related complications, etc.
Study Oversight
Has Oversight DMC:
True
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?: