Validation of a Smartphone-based Recorder for Detection of Cardiac Arrhythmias
Primary Purpose
Cardiac Arrhythmia
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Alivecor recording
Sponsored by
About this trial
This is an interventional diagnostic trial for Cardiac Arrhythmia
Eligibility Criteria
Inclusion Criteria:
- Male or female patients >18 years
- 12 lead ECG finding of arrhythmia, manifest pre-excitation, pacing rhythm (in the EP lab), sinus rhythm or sinus tachycardia
Exclusion Criteria:
- Age <18 years
- Patients unable to or unwilling to use the device
- Patients with cardiac pacemaker, ICDs, or other implanted electronic devices
Sites / Locations
- Blackpool Teaching Hospitals NHS Foundation TrustRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Normal ECGs
Abnormal ECGs
Arm Description
Patients with normal ECGs
Patients with different kinds of abnormal heart rhythms will be enrolled in order to compare whether Alivecor can accurately differentiate between these abnormal heart rhythms and normal sinus rhythm/sinus tachycardia. Also, Alivecor diagnostic accuracy in differentiating between different kinds of arrhythmias will be assessed.
Outcomes
Primary Outcome Measures
Diagnostic accuracy of alivecor recording
For each patient two diagnoses of their underlying heart rhythm will be provided by blinded reporters. The percentage match of these diagnoses (the ratio of identical diagnoses to mismatch in diagnoses between ECG report and Alivecor report will be used as a measure of accuracy of the Alivecor to differentiate between different heart rhythms, using the 12 lead ECG as the gold standard for cardiac rhythm diagnosis.
Secondary Outcome Measures
Full Information
NCT ID
NCT03996954
First Posted
May 28, 2019
Last Updated
September 14, 2020
Sponsor
Blackpool Teaching Hospitals NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT03996954
Brief Title
Validation of a Smartphone-based Recorder for Detection of Cardiac Arrhythmias
Official Title
Validation of a Smartphone-based Recorder for Detection of Cardiac Arrhythmias
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 8, 2018 (Actual)
Primary Completion Date
October 7, 2020 (Anticipated)
Study Completion Date
October 7, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Blackpool Teaching Hospitals NHS Foundation Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
The investigators will evaluate the diagnostic yield of the new AliveCor device versus a 12 lead ECG when used simultaneously to detect cardiac arrhythmia
Detailed Description
The investigators are planning to record 250 pre-defined abnormal ECGs (50 each of atrial fibrillation, atrial flutter, pre-excitation, ventricular tachycardia, , supraventricular tachycardia) and 150 control ECGs (100 sinus rhythm, 50 sinus tachycardia) using both the AliveCor Smartphone device and a 12-lead ECG. All 400 ECGs will then be read by 3 blinded reporters - a Consultant Electrophysiologist, a Consultant General Cardiologist and a General Practitioner. The output of the AliveCor automatic detection algorithm will also be recorded as a fourth reporter. The screening characteristics of all 4 reporters using the AliveCor device vs the definitive 12 lead ECG will be analysed and compared.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrhythmia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Recordings with Alivecor and 12 lead ECGs with be acquired from patients with known arrhythmias/normal heart rhythm and blinded physicians will report on recordings and ECGs. Reports for each patient will be compared at the end of the study in order to assess diagnostic accuracy of the Alivecor to detect and differentiate between different kinds of abnormal heart rhythms.
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Normal ECGs
Arm Type
Active Comparator
Arm Description
Patients with normal ECGs
Arm Title
Abnormal ECGs
Arm Type
Active Comparator
Arm Description
Patients with different kinds of abnormal heart rhythms will be enrolled in order to compare whether Alivecor can accurately differentiate between these abnormal heart rhythms and normal sinus rhythm/sinus tachycardia. Also, Alivecor diagnostic accuracy in differentiating between different kinds of arrhythmias will be assessed.
Intervention Type
Device
Intervention Name(s)
Alivecor recording
Intervention Description
Alivecor recording and ECG recording from the same patient in very close temporal proximity
Primary Outcome Measure Information:
Title
Diagnostic accuracy of alivecor recording
Description
For each patient two diagnoses of their underlying heart rhythm will be provided by blinded reporters. The percentage match of these diagnoses (the ratio of identical diagnoses to mismatch in diagnoses between ECG report and Alivecor report will be used as a measure of accuracy of the Alivecor to differentiate between different heart rhythms, using the 12 lead ECG as the gold standard for cardiac rhythm diagnosis.
Time Frame
Diagnostic accuracy of Alivecor recording at the end of the study which will be 2 years after study start date.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or female patients >18 years
12 lead ECG finding of arrhythmia, manifest pre-excitation, pacing rhythm (in the EP lab), sinus rhythm or sinus tachycardia
Exclusion Criteria:
Age <18 years
Patients unable to or unwilling to use the device
Patients with cardiac pacemaker, ICDs, or other implanted electronic devices
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Khalid Abozguia, Ph.D.
Phone
00441253957780
Email
k.abozguia@nhs.net
First Name & Middle Initial & Last Name or Official Title & Degree
Dimitrios Katsaras, MD
Phone
00441253957780
Email
d.katsaras@nhs.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khalid Abozguia, Ph.D.
Organizational Affiliation
Blackpool Teaching Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Blackpool Teaching Hospitals NHS Foundation Trust
City
Blackpool
State/Province
Lancashire
ZIP/Postal Code
FY3 8NR
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Khalid Abozguia, PhD
Phone
00441253957780
Email
k.abozguia@nhs.net
First Name & Middle Initial & Last Name & Degree
Dimitrios Katsaras, MD
Phone
00441253957780
Email
d.katsaras@nhs.net
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Validation of a Smartphone-based Recorder for Detection of Cardiac Arrhythmias
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