Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2025-12-25 @ 1:08 AM
NCT ID:
NCT03339193
Eligibility Criteria:
Patients who meet current clinical criteria for LAAC, ie have atrial fibrillation, a CHA2DS2-VASc score of 3 or more and a contraindication to long-term oral anticoagulation therapy and who have been approved by the Oxford University Hospitals (OUH) NHS Foundation Trust LAAC MDT as suitable for left atrial appendage occlusion in accordance with NHS guidelines.
A subject will be considered for enrolment in the study if all of the following inclusion criteria are met, provided no exclusion criteria are met:
Inclusion Criteria:
* Subjects who are eligible for a WATCHMAN FLX device per physician discretion according to current international and local guidelines and currently approved indications
* Subjects 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 national law.
Exclusion Criteria:
* Subjects 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.
* Subjects who are unable or not willing to complete the follow-up visits and examination at 6 weeks.
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT03339193
Study Brief:
Protocol Section:
NCT03339193