N/A
N=50
Observe the Safety and Effectiveness of the WATCHMAN FLX™ for Subjects in Hong Kong
Non-valvular Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT04096963 ↗Enrolled (actual)
50
Serious AEs
46.0%
Results posted
Aug 2024
Primary outcome: Primary: Primary Effectiveness Endpoint — 0 percentage of occurence
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- The WATCHMAN FLX Delivery System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Effectiveness Endpoint |
— | — |
| PRIMARY Primary Safety Endpoint |
2.0 | — |
| SECONDARY Secondary Endpoint |
0; 1 | — |
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 reduce the risk of stroke in Hong Kong area.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04096963). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.