stop_circleTerminated/Withdrawn
Atrial Fibrillation
Bayer Identifier:
18250
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Atrial fibrillation screening with a smartphone device and iECG application
Trial purpose
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
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
Key Participants Requirements
Sex
BothAge
65 - N/ATrial summary
Enrollment Goal
0Trial Dates
October 2015 - April 2016Phase
N/ACould I Receive a placebo
NoProducts
No DrugAccepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Withdrawn | Many Locations, Colombia |
Primary Outcome
- Number of patients screened in whom the screening device detect an abnormal cardiac rhythmdate_rangeTime Frame:Up to 6 monthsenhanced_encryptionNoSafety Issue:
- Number of patients screened in whom Atrial Fibrillation (AF) was confirmed with ECGdate_rangeTime Frame:Up to 6 monthsenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Number of patients in whom abnormal cardiac rhythm was detected with screening device and AF was confirmed with ECGPredictive 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 rhythmdate_rangeTime Frame:Up to 6 monthsenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
OtherTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A