CompletedNot Applicable

Observe the Safety and Effectiveness of the WATCHMAN FLX™ for Subjects in Hong Kong

China50 participantsStarted 2020-06-19

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

Primary Effectiveness Endpoint

Timeframe: First Follow-up (30 ~ 100 days);

Primary Safety Endpoint

Timeframe: First Follow-up (30-100 days)

Trial details

NCT IDNCT04096963

SponsorBoston Scientific Corporation

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-01-24

Results submitted2022-07-18

View on ClinicalTrials.gov More Non-valvular Atrial Fibrillation trials