Cardiac ArrhythmiaNCT03996954
Validation of a Smartphone-based Recorder for Detection of Cardiac Arrhythmias
A study testing Alivecor recording in people with Cardiac Arrhythmia, run by Blackpool Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Arrhythmia
- What is being tested?
- Alivecor recording
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Oct 2018to 7 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age <18 years
- Patients unable to or unwilling to use the device
- Patients with cardiac pacemaker, ICDs, or other implanted electronic devices
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Blackpool Teaching Hospitals NHS Foundation Trust
Blackpool, Lancashire, FY3 8NR
Khalid Abozguia, PhD, 00441253957780, k.abozguia@nhs.net
Dimitrios Katsaras, MD, 00441253957780, d.katsaras@nhs.net
About this study
The investigators will evaluate the diagnostic yield of the new AliveCor device versus a 12 lead ECG when used simultaneously to detect cardiac arrhythmia
Read the 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.
- Conditions
- Cardiac Arrhythmia
- Being tested
- Alivecor recording
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alivecor recordingDevice
Alivecor recording and ECG recording from the same patient in very close temporal proximity
| Study group | Role | What they receive |
|---|---|---|
| Normal ECGs | Active comparator | Patients with normal ECGs Receives: Device: Alivecor recording |
| Abnormal ECGs | Active comparator | 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. Receives: Device: Alivecor recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Diagnostic accuracy of Alivecor recording at the end of the study which will be 2 years after study start date.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start8 Oct 2018
- Primary completion7 Oct 2020 (estimated)
- Study completion7 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Blackpool Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Khalid Abozguia, Blackpool Teaching Hospitals NHS Foundation Trust
- Investigators
- Khalid Abozguia, Ph.D., Principal investigator, Blackpool Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03996954
- Sponsor's protocol ID
- IRAS Project ID:245687
- Status last verified
- Sep 2020
- First submitted
- 28 May 2019
- Last updated
- 16 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Smartphone-based Recorder for Detection of Cardiac Arrhythmias
- ClinicalTrials.gov ID
- NCT03996954
- Acronym / sponsor ID
- IRAS Project ID:245687
- Conditions
- Cardiac Arrhythmia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Blackpool Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 8 Oct 2018 (actual)
- Primary completion
- 7 Oct 2020 (estimated)
- Study completion
- 7 Oct 2020 (estimated)
- First posted
- 25 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Normal ECGs | Active comparator | Device: Alivecor recordingPatients with normal ECGs |
| Abnormal ECGs | Active comparator | Device: Alivecor recordingPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Age <18 years
- Patients unable to or unwilling to use the device
- Patients with cardiac pacemaker, ICDs, or other implanted electronic devices
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alivecor recordingAlivecor recording and ECG recording from the same patient in very close temporal proximity | Device | Abnormal ECGs, Normal ECGs |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khalid Abozguia, Ph.D. principal investigator
Blackpool Teaching Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alivecor recording in people with Cardiac Arrhythmia, run by Blackpool Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Khalid Abozguia, Ph.D. (00441253957780, k.abozguia@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.