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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03651323
Other study ID # ISRCAR00144
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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