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Atrial Fibrillation Screening With a Smartphone Device and iECG Application

Atrial Fibrillation Screening With a Smartphone Device and iECG Application

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02534532
Acronym
AFScreenCol
Enrollment
0
Registered
2015-08-27
Start date
2015-10-31
Completion date
2016-04-30
Last updated
2015-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation screening

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

Interventions

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

Sponsors

Bayer
Lead SponsorINDUSTRY

Study design

Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Number of patients screened in whom the screening device detect an abnormal cardiac rhythmUp to 6 months
Number of patients screened in whom Atrial Fibrillation (AF) was confirmed with ECGUp to 6 months

Secondary

MeasureTime frameDescription
Number of patients in whom abnormal cardiac rhythm was detected with screening device and AF was confirmed with ECGUp to 6 monthsPredictive 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026