NCT03651323

Latin America Registry on WatchmanTM Outcomes in Real Life

Left Atrial Appendage Closure for Stroke Prevention in Atrial Fibrillation: Latin America Registry on WatchmanTM Outcomes in Real Life

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Centro Medico Docente la Trinidad · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Left atrial appendage closure with Watchman device	Percutaneous left atrial appendage closure using Watchman device

Timeline

• Start date: 2018-10-01
• Primary completion: 2018-11-01
• Completion: 2018-12-01
• First posted: 2018-08-29
• Last updated: 2018-08-29

Locations

1 site across 1 country: Venezuela

Regulatory

• FDA-regulated device study