stop_circleTerminated/Withdrawn

Atrial Fibrillation

Bayer Identifier:

18250

ClinicalTrials.gov Identifier:

NCT02534532

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

Key Participants Requirements

Sex

Both

Age

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

  • - 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

Trial summary

Enrollment Goal
0
Trial Dates
October 2015 - April 2016
Phase
N/A
Could I Receive a placebo
No
Products
No Drug
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Withdrawn
Many Locations, Colombia

Primary Outcome

  • Number of patients screened in whom the screening device detect an abnormal cardiac rhythm
    date_rangeTime Frame:
    Up to 6 months
    enhanced_encryption
    Safety Issue:
    No
  • Number of patients screened in whom Atrial Fibrillation (AF) was confirmed with ECG
    date_rangeTime Frame:
    Up to 6 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Number of patients in whom abnormal cardiac rhythm was detected with screening device and AF was confirmed with ECG
    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
    date_rangeTime Frame:
    Up to 6 months
    enhanced_encryption
    Safety Issue:
    No

Trial design

Atrial fibrillation screening with a smartphone device and iECG application
Trial Type
Observational
Intervention Type
Other
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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