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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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