Watchman FLX Left Atrial Appendage Closure Device Post Approval Study ( Europe Only)
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Watchman FLX Left Atrial Appendage Closure Device Post Approval Study
Condition or disease
Non-valvular Atrial Fibrillation
Device: Watchman FLX
WATCHMAN FLX is intended to prevent thrombus embolization from the left atrial appendage and reduce the risk of life-threatening bleeding events in patients with non-valvular atrial fibrillation who are eligible for anticoagulation therapy or who have a contraindication to anticoagulation therapy.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
All subjects who meet all inclusion and no exclusion criteria can be enrolled. A subject who signs informed consent is considered enrolled in the study. The subjects selected for participation will be from the investigator's general patient population.
Subjects who are eligible for a WATCHMAN FLX device according to current international and local guidelines and currently approved indications;
Subject who are willing and capable of providing informed consent and participating in all testing associated with this clinical investigation at an approved clinical investigational centre;
Subjects whose age is 18 years or above, or of legal age to give informed consent specific to state and national law.
Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the Subject 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
The subject is unable or not willing to complete follow-up visits and examinations for the duration of the study
Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion);
Documented life expectancy of less than 12 months.