Watchman FLX Left Atrial Appendage Closure Device Post Approval Study

Boston Scientific Corporation17 sites in 9 countries300 target enrollmentJuly 16, 2019

ConditionsNon-valvular Atrial Fibrillation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Non-valvular Atrial Fibrillation
Sponsor: Boston Scientific Corporation
Enrollment: 300
Locations: 17
Primary Endpoint: procedural complications
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Watchman FLX Left Atrial Appendage Closure Device Post Approval Study

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

July 16, 2019

End Date

September 28, 2021

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Boston Scientific Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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.