Atrial FibrillationiReadNCT02214069
Using Smart Phone Technology in Detecting the Presence of Atrial Fibrillation
An observational study of Atrial Fibrillation and Atrial Flutter, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The purpose of this study is to examine whether patients can use the AliveCor case to record their heart rhythm and to assess the accuracy of the software in detecting AF vs sinus rhythm Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Atrial Flutter
- What is being tested?
- Record and transmit heart rhythm
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Jul 2017
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the hospital for your atrial fibrillation or atrial flutter
Who may be able to join
- Male or female between > 18 and < 80 years of age
- Paroxysmal or persistent atrial fibrillation
- Admitted for antiarrhythmic drug loading (Dofetilide or Sotalol)
- Already has iPhone 4, 4S or 5 with data plan that accommodates the AliveCor case
- Willing to use the Alive Cor case
- Written informed consent
Who cannot join
- Unable or unwilling to use the Alive Cor case for their smart phone
- Presence of a permanent pacemaker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Accuracy of an Atrial Fibrillation Detection Algorithm Using Novel Smart Phone Technology in Detecting the Presence of Atrial Fibrillation. iRead Study
The purpose of this study is to examine whether patients can use the AliveCor case to record their heart rhythm and to assess the accuracy of the software in detecting AF vs sinus rhythm
Read the detailed description
AliveCor is a new monitoring technology used with a smart phone which allows patients to record their rhythm. The study will compare AliveCor recordings and automated interpretation of the rhythm with the interpretation by an Electrophysiologist.
- Conditions
- Atrial Fibrillation, Atrial Flutter
- Being tested
- Record and transmit heart rhythm
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Record and transmit heart rhythmDevice
The patient uses the AliveCor device to record and transmit heart rhythm two times a day. The patient, device software, and Electrophysiologist interpret the rhythm
| Study group | Role | What they receive |
|---|---|---|
| Patients with Atrial Fibrillation | Patients with Atrial Fibrillation admitted to the hospital for drug loading with Dofetilide or Sotalol willing to record and transmit heart rhythm using AliveCor. Receives: Device: Record and transmit heart rhythm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examine the accuracy of the AliveCor software in detecting AF or sinus rhythm compared to the physician interpretation
Both the software nd overreading electrophysiologist come to the same conclusion regarding the rhythm of the ECG and Alivecor reading. Both determining that the tracing is either normal sinus rhythm or atrial fibrillation.
Measured: 6 month
Secondary outcomes (1)
Assess the correlation between QT interval derived from the AliveCor device compared to standard 12 lead ECG, as assessed by the overreading electrophysiologists.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionOct 2016
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- AliveCor
- Responsible party
- Principal investigator, Khaldoun Tarakji, The Cleveland Clinic
- Investigators
- Khaldoun Tarakji, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02214069
- Sponsor's protocol ID
- 14-612
- Acronym
- iRead
- Status last verified
- Dec 2017
- First submitted
- 6 Aug 2014
- Last updated
- 13 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
William AD, Kanbour M, Callahan T, Bhargava M, Varma N, Rickard J, Saliba W, Wolski K, Hussein A, Lindsay BD, Wazni OM, Tarakji KG. Assessing the accuracy of an automated atrial fibrillation detection algorithm using smartphone technology: The iREAD Study. Heart Rhythm. 2018 Oct;15(10):1561-1565. doi: 10.1016/j.hrthm.2018.06.037. Epub 2018 Aug 22.
PubMed 30143448
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Accuracy of an Atrial Fibrillation Detection Algorithm Using Novel Smart Phone Technology in Detecting the Presence of Atrial Fibrillation. iRead Study
- ClinicalTrials.gov ID
- NCT02214069
- Acronym / sponsor ID
- iRead / 14-612
- Conditions
- Atrial Fibrillation, Atrial Flutter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- AliveCor
- Study start
- Aug 2014 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 12 Aug 2014 (estimated)
- 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 purpose of this study is to examine whether patients can use the AliveCor case to record their heart rhythm and to assess the accuracy of the software in detecting AF vs sinus rhythm
Detailed description
AliveCor is a new monitoring technology used with a smart phone which allows patients to record their rhythm. The study will compare AliveCor recordings and automated interpretation of the rhythm with the interpretation by an Electrophysiologist.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Atrial Fibrillation | – | Device: Record and transmit heart rhythmPatients with Atrial Fibrillation admitted to the hospital for drug loading with Dofetilide or Sotalol willing to record and transmit heart rhythm using AliveCor. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the hospital for your atrial fibrillation or atrial flutter
Key inclusion criteria (6 listed)
- Male or female between > 18 and < 80 years of age
- Paroxysmal or persistent atrial fibrillation
- Admitted for antiarrhythmic drug loading (Dofetilide or Sotalol)
- Already has iPhone 4, 4S or 5 with data plan that accommodates the AliveCor case
- Willing to use the Alive Cor case
Key exclusion criteria (2 listed)
- Unable or unwilling to use the Alive Cor case for their smart phone
- Presence of a permanent pacemaker
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 |
|---|---|---|
| Record and transmit heart rhythmThe patient uses the AliveCor device to record and transmit heart rhythm two times a day. The patient, device software, and Electrophysiologist interpret the rhythm | Device | Patients with Atrial Fibrillation |
Primary outcome
Examine the accuracy of the AliveCor software in detecting AF or sinus rhythm compared to the physician interpretation
Time frame: 6 month
Both the software nd overreading electrophysiologist come to the same conclusion regarding the rhythm of the ECG and Alivecor reading. Both determining that the tracing is either normal sinus rhythm or atrial fibrillation.
1 secondary outcome
Assess the correlation between QT interval derived from the AliveCor device compared to standard 12 lead ECG, as assessed by the overreading electrophysiologists.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
- Derived from this study: PubMed 30143448William AD, Kanbour M, Callahan T, Bhargava M, Varma N, Rickard J, Saliba W, Wolski K, Hussein A, Lindsay BD, Wazni OM, Tarakji KG. Assessing the accuracy of an automated atrial fibrillation detection algorithm using smartphone technology: The iREAD Study. Heart Rhythm. 2018 Oct;15(10):1561-1565. doi: 10.1016/j.hrthm.2018.06.037. Epub 2018 Aug 22.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
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.
Khaldoun Tarakji, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Atrial Flutter, run by The Cleveland Clinic at 1 site in United States.
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 6 inclusion and 2 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: finished, as of the sponsor's last update on 13 Dec 2017. 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 States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Examine the accuracy of the AliveCor software in detecting AF or sinus rhythm compared to the physician interpretation (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02214069, which also lists 1 linked publication.
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 13 Dec 2017.