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Atrial Fibrillation Screening With a Smartphone Device and iECG Application

NCT ID: NCT02534532

Last Updated: 2015-11-25

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

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-04-30

Brief Summary

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Question: Can atrial fibrillation (AF) cases in patients ≥ 65 years be easily detected in a primary healthcare environment using a smartphone device and iECG application as an opportunistic screening tool?

Objectives:

Detection of AF through cardiac rhythm abnormalities in patients ≥65 years old in an opportunistic screening program using a smartphone device/application

1. Define the predictable value of the smartphone device with electrocardiogram (ECG) confirmation to detect AF in patients 65 years and older
2. Correlate screened patients cardiovascular risk profile and those that register cardiac rhythm irregularities for a better description of the general characteristics of Colombian population

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Cohort 1

Females and males ≥65 years old, attending to the primary care centers, located in three different major cities in Colombia, that are willing to participate in the study, and do not present any exclusion criteria

AF screening

Intervention Type OTHER

Screening of AF in an opportunistic screening program using a smartphone device/application confirmed by ECG

Interventions

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AF screening

Screening of AF in an opportunistic screening program using a smartphone device/application confirmed by ECG

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Females and males patients ≥65 years old attending primary care counselling
* Written informed consent

Exclusion Criteria

* Patients with confirmed diagnosis of AF
* Patients who do not want to participate
* Patients consulting for acute conditions
* Patients presenting any diagnosed arrhythmia different than AF
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Other Identifiers

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18250

Identifier Type: -

Identifier Source: org_study_id