Validation of a Smartphone-based Recorder for Detection of Cardiac Arrhythmias

NCT ID: NCT03996954

Last Updated: 2020-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-08

Study Completion Date

2020-10-07

Brief Summary

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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

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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.

Conditions

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Cardiac Arrhythmia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Normal ECGs

Patients with normal ECGs

Group Type ACTIVE_COMPARATOR

Alivecor recording

Intervention Type DEVICE

Alivecor recording and ECG recording from the same patient in very close temporal proximity

Abnormal 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.

Group Type ACTIVE_COMPARATOR

Alivecor recording

Intervention Type DEVICE

Alivecor recording and ECG recording from the same patient in very close temporal proximity

Interventions

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Alivecor recording

Alivecor recording and ECG recording from the same patient in very close temporal proximity

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Blackpool Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Dr. Khalid Abozguia

Consultant Cardiologist and Electrophysiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Khalid Abozguia, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Blackpool Teaching Hospitals NHS Foundation Trust

Locations

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Blackpool Teaching Hospitals NHS Foundation Trust

Blackpool, Lancashire, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Khalid Abozguia, Ph.D.

Role: CONTACT

00441253957780

Dimitrios Katsaras, MD

Role: CONTACT

00441253957780

Facility Contacts

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Khalid Abozguia, PhD

Role: primary

00441253957780

Dimitrios Katsaras, MD

Role: backup

00441253957780

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IRAS Project ID:245687

Identifier Type: -

Identifier Source: org_study_id

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