Validation of a Smartphone-based Recorder for Detection of Cardiac Arrhythmias
NCT ID: NCT03996954
Last Updated: 2020-09-16
Study Results
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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UNKNOWN
NA
400 participants
INTERVENTIONAL
2018-10-08
2020-10-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Normal ECGs
Patients with normal ECGs
Alivecor recording
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.
Alivecor recording
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
Eligibility Criteria
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Inclusion Criteria
* 12 lead ECG finding of arrhythmia, manifest pre-excitation, pacing rhythm (in the EP lab), sinus rhythm or sinus tachycardia
Exclusion Criteria
* Patients unable to or unwilling to use the device
* Patients with cardiac pacemaker, ICDs, or other implanted electronic devices
18 Years
ALL
Yes
Sponsors
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Blackpool Teaching Hospitals NHS Foundation Trust
OTHER
Responsible Party
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Dr. Khalid Abozguia
Consultant Cardiologist and Electrophysiologist
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
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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IRAS Project ID:245687
Identifier Type: -
Identifier Source: org_study_id
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