Left Atrial Appendage Closure for Stroke Prevention in Atrial Fibrillation: Latin America Registry on WatchmanTM Outcomes in Real Life
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- Centro Medico Docente la Trinidad
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Incidence of Periprocedural complications
- Last Updated
- 7 years ago
Overview
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.
Investigators
Luis Cressa
Interventional Cardiologist
Centro Medico Docente la Trinidad
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Incidence of Periprocedural complications
Time Frame: At implant
Pericardial effusion, stroke, device embolization and bleeding
Incidence of Stroke
Time Frame: 6 months follow up
Stroke
Incidence of Death
Time Frame: 6 months follow up
Cardiovascular and no cardiovascular death