- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03996954
Validation of a Smartphone-based Recorder for Detection of Cardiac Arrhythmias
September 14, 2020 updated by: Dr. Khalid Abozguia, Blackpool Teaching Hospitals NHS Foundation Trust
The investigators will evaluate the diagnostic yield of the new AliveCor device versus a 12 lead ECG when used simultaneously to detect cardiac arrhythmia
Study Overview
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.
Study Type
Interventional
Enrollment (Anticipated)
400
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Khalid Abozguia, Ph.D.
- Phone Number: 00441253957780
- Email: k.abozguia@nhs.net
Study Contact Backup
- Name: Dimitrios Katsaras, MD
- Phone Number: 00441253957780
- Email: d.katsaras@nhs.net
Study Locations
-
-
Lancashire
-
Blackpool, Lancashire, United Kingdom, FY3 8NR
- Recruiting
- Blackpool Teaching Hospitals NHS Foundation Trust
-
Contact:
- Dimitrios Katsaras, MD
- Phone Number: 00441253957780
- Email: d.katsaras@nhs.net
-
Contact:
- Khalid Abozguia, PhD
- Phone Number: 00441253957780
- Email: k.abozguia@nhs.net
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Normal ECGs
Patients with normal ECGs
|
Alivecor recording and ECG recording from the same patient in very close temporal proximity
|
Active Comparator: 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 and ECG recording from the same patient in very close temporal proximity
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnostic accuracy of alivecor recording
Time Frame: Diagnostic accuracy of Alivecor recording at the end of the study which will be 2 years after study start date.
|
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.
|
Diagnostic accuracy of Alivecor recording at the end of the study which will be 2 years after study start date.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Khalid Abozguia, Ph.D., Blackpool Teaching Hospitals NHS Foundation Trust
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 8, 2018
Primary Completion (Anticipated)
October 7, 2020
Study Completion (Anticipated)
October 7, 2020
Study Registration Dates
First Submitted
May 28, 2019
First Submitted That Met QC Criteria
June 22, 2019
First Posted (Actual)
June 25, 2019
Study Record Updates
Last Update Posted (Actual)
September 16, 2020
Last Update Submitted That Met QC Criteria
September 14, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRAS Project ID:245687
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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