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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
Blackpool Teaching Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cardiac Arrhythmia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
May 28, 2019
Last Updated
September 14, 2020
Sponsor
Blackpool Teaching Hospitals NHS Foundation Trust
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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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