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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03651323

Acronym

LATINAWERICA

Enrollment

500

Registered

2018-08-29

Start date

2018-10-01

Completion date

2018-12-01

Last updated

2018-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation, Left atrial appendage, Stroke

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.

Interventions

DEVICELeft atrial appendage closure with Watchman device

Percutaneous left atrial appendage closure using Watchman device

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Venezuela

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026