Latin America Registry on WatchmanTM Outcomes in Real Life (LATINAWERICA)

Centro Medico Docente la Trinidad

Status: Unknown

Conditions: Atrial Fibrillation

Treatments: Device: Left atrial appendage closure with Watchman device

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03651323

ISRCAR00144

Details and patient eligibility

About

Left atrial appendage (LAA) occlusion with WatchmanTM has emerged as viable alternative to anticoagulation therapy in randomized controlled trials. The device has FDA approved since 2015 and the firsts Latin American cases were performed in 2012. However, there is no real world data from Latin American experience in terms of success and outcomes.

Full description

Approximately 450 subjects will be enrolled in the study. Up to 50 sites in Latin America will participate in the study.

Primary analyses may include, but will not be limited to, the following: procedural complications, incidence of stroke and death. Descriptive statistics will be used for baseline, procedure and follow-up data collected through the registry.

Clinical history of each patient will be analyzed for a period of 6 months after the procedure according the standard practice at the enrolling centers. There will be no additional visits, nor procedures, for subjects in the registry.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who were eligible for a WatchmanTM device implantation according to current international and local guidelines and per physician and institution discretion.

Exclusion criteria

• Patient who were currently enrolled in another investigational study or registry that would directly interfere with the current study aims.