Latin America Registry on WatchmanTM Outcomes in Real Life

• Conditions: Atrial Fibrillation

• Registration Number: NCT03651323
• Lead Sponsor: Centro Medico Docente la Trinidad

Brief 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.

Study Timeline

• Status Verified: 2018-08
• Study First Submitted: 2018-08-24
• Study First Submitted QC: 2018-08-27
• Last Update Submitted: 2018-08-27
• Study First Posted: 2018-08-29
• Last Update Posted: 2018-08-29
• Study Start: 2018-10-01
• Primary Completion: 2018-11-01
• Study Completion: 2018-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Periprocedural complications	At implant	Pericardial effusion, stroke, device embolization and bleeding
Incidence of Stroke	6 months follow up	Stroke
Incidence of Death	6 months follow up	Cardiovascular and no cardiovascular death

Trial Locations

Locations (1)

Centro Medico Docente la Trinidad; 🇻🇪 Caracas, Miranda, Venezuela