NCT03651323

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 29, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

August 29, 2018

Status Verified

August 1, 2018

Enrollment Period

1 month

First QC Date

August 24, 2018

Last Update Submit

August 27, 2018

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillationLeft atrial appendageStroke

Outcome Measures

Primary Outcomes (3)

  • Incidence of Periprocedural complications

    Pericardial effusion, stroke, device embolization and bleeding

    At implant

  • Incidence of Stroke

    Stroke

    6 months follow up

  • Incidence of Death

    Cardiovascular and no cardiovascular death

    6 months follow up

Interventions

Left atrial appendage closure with Watchman deviceDEVICE

Percutaneous left atrial appendage closure using Watchman device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with atrial fibrillation and indication for left atrial appendage closure

You may qualify if:

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

You may not qualify if:

  • Patient who were currently enrolled in another investigational study or registry that would directly interfere with the current study aims.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Medico Docente la Trinidad

Caracas, Miranda, 1080, Venezuela

Location

MeSH Terms

Conditions

Atrial FibrillationStroke

Interventions

Left Atrial Appendage Closure

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac CatheterizationCatheterizationTherapeuticsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Interventional Cardiologist

Study Record Dates

First Submitted

August 24, 2018

First Posted

August 29, 2018

Study Start

October 1, 2018

Primary Completion

November 1, 2018

Study Completion

December 1, 2018

Last Updated

August 29, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

VE(1)