Atrial Fibrillation Screening With a Smartphone Device and iECG Application

Withdrawn

• Conditions: Atrial Fibrillation
• Interventions: Other: AF screening

• Registration Number: NCT02534532
• Lead Sponsor: Bayer

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2015-08-19
• Study First Submitted QC: 2015-08-26
• Study First Posted: 2015-08-27
• Study Start: 2015-10
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-24
• Last Update Posted: 2015-11-25
• Primary Completion: 2016-04
• Study Completion: 2016-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1	AF screening	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

Primary Outcome Measures

Name	Time	Method
Number of patients screened in whom the screening device detect an abnormal cardiac rhythm	Up to 6 months
Number of patients screened in whom Atrial Fibrillation (AF) was confirmed with ECG	Up to 6 months

Secondary Outcome Measures

Name	Time	Method
Number of patients in whom abnormal cardiac rhythm was detected with screening device and AF was confirmed with ECG	Up to 6 months	Predictive value tests - Positive: Number of patients screened in whom AF was confirmed with ECG/ Number of patients screened in whom the screening device detect an abnormal rhythm - Negative: Number of patients screened in whom AF was discarded with ECG/ Number of patients screened in whom the screening device detect an abnormal rhythm