Latin America Registry on WatchmanTM Outcomes in Real Life

Atrial Fibrillation Clinical Trial

— LATINAWERICA  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03651323
• Other study ID #: ISRCAR00144
• Status: Enrolling by invitation
• Start date: October 1, 2018
• Est. completion date: December 1, 2018

Study information

• Verified date: August 2018
• Source: Centro Medico Docente la Trinidad
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: December 1, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Left atrial appendage closure with Watchman device
Percutaneous left atrial appendage closure using Watchman device

Locations

Country	Name	City	State
Venezuela	Centro Medico Docente la Trinidad	Caracas	Miranda

Sponsors (2)

Lead Sponsor	Collaborator
Centro Medico Docente la Trinidad	Boston Scientific Corporation

Country where clinical trial is conducted

Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Periprocedural complications	Pericardial effusion, stroke, device embolization and bleeding	At implant
Primary	Incidence of Stroke	Stroke	6 months follow up
Primary	Incidence of Death	Cardiovascular and no cardiovascular death	6 months follow up