Status:
COMPLETED
Observe the Safety and Effectiveness of the WATCHMAN FLX™ for Subjects in Hong Kong
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Non-valvular Atrial Fibrillation
Eligibility:
All Genders
18+ years
Brief Summary
The primary objective of this study is to observe the safety and effectiveness of the WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device for subjects with non-valvular atrial fibrillation to re...
Detailed Description
This study is a prospective, non-randomized, multi-center observational study. The primary Effectiveness Endpoint is the occurrence of non-effective LAA closure defined as any peri-device flow \> 5mm ...
Eligibility Criteria
Inclusion
- Patients who are eligible for a WATCHMAN FLX device according to current international and local guidelines (and future revisions) and per physician discretion;
- Patients who are willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center;
- Patients whose age is 18 years or above, or of legal age to give informed consent specific to state and national law.
Exclusion
- Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility.
- Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion);
- The subject is unable or not willing to complete follow-up visits and examination for the duration of the study.
Key Trial Info
Start Date :
June 19 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 28 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04096963
Start Date
June 19 2020
End Date
March 28 2023
Last Update
August 12 2024
Active Locations (1)
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1
Queen Mary Hospital
Hong Kong, China