Watchman FLX Left Atrial Appendage Closure Device Post Approval Study ( Europe Only)

Launched by BOSTON SCIENTIFIC CORPORATION · Jan 11, 2016

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subjects who are eligible for a WATCHMAN FLX device according to current international and local guidelines and currently approved indications;
• • 2. 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;
• • 3. Subjects whose age is 18 years or above, or of legal age to give informed consent specific to state and national law.
• Exclusion Criteria:
• • 1. 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
• • 2. The subject is unable or not willing to complete follow-up visits and examinations for the duration of the study
• • 3. Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion);
• • 4. Documented life expectancy of less than 12 months.