Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2026-02-19 @ 4:43 AM
Study NCT ID:
NCT02534532
Status:
WITHDRAWN
Last Update Posted:
2015-11-25
First Post:
2015-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atrial Fibrillation Screening With a Smartphone Device and iECG Application
Sponsor:
Bayer
Organization:
Study Overview
Official Title:
Atrial Fibrillation Screening With a Smartphone Device and iECG Application
Status:
WITHDRAWN
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AFScreenCol
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
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: