Latin America Registry on WatchmanTM Outcomes in Real Life

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-01

Study Completion Date

2018-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Registry on WATCHMAN Outcomes in Real-Life Utilization

NCT01972282

Patients With Atrial Fibrillation at Risk for Thrombus Formation, Thromboembolism, Stroke

COMPLETED

WATCHMAN for Concomitant Left Atrial Appendage Electrical Isolation and Occlusion to Treat Persistent Atrial Fibrillation Rhythm

NCT03835338

Persistent Atrial Fibrillation

WITHDRAWN NA

Investigational Device Evaluation of the WATCHMAN FLX™ LAA Closure Technology

NCT02702271

Atrial Fibrillation

COMPLETED NA

Evaluation of the WATCHMAN Left Atrial Appendage (LAA) Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy

NCT01182441

Atrial Fibrillation Stroke

COMPLETED PHASE3

Procedure RElated Outcomes With the Watchman FLX Left Atrial Appendage Closure Device

NCT03339193

Atrial Fibrillation Stroke

WITHDRAWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Fibrillation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Left atrial appendage closure with Watchman device

Percutaneous left atrial appendage closure using Watchman device

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients who were eligible for a WatchmanTM device implantation according to current international and local guidelines and per physician and institution discretion.