Arrhythmia, Palpitations, LightheadednessNCT02005172
Validation of an iPhone-based Event Recorder for Arrhythmia Detection
A study testing Alivecor monitor and 14 day event monitor in people with Arrhythmia, Palpitations, Lightheadedness, run by University at Buffalo at 1 site in United States.
Trial summary
In this study, we will evaluate the diagnostic yield of the new AliveCor device versus a 14 day event monitor with the use of both devices simultaneously. We will also examine by means of a questionnaire the compliance, ease of use and patient satisfaction for each device. Hypothesis: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmia, Palpitations, Lightheadedness
- What is being tested?
- Alivecor monitor and 14 day event monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to May 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients >18 years of age with symptoms such as palpitations or pre-syncope suggestive of arrhythmias (usually occurring less frequently than once a day) with prior non-diagnostic ECGs and/or Holter monitoring.
- Patients who own an iPhone 4, 4S or 5 device and demonstrate the capability of recording and uploading a test ECG recording at the office visit.
Who cannot join
- Patients <18 years of age.
- Patients with a myocardial infarction (MI) within the last three months, and/or known history of sustained VT/VF.
- Patients with NYHA class IV heart failure.
- Patients with unstable angina.
- Patients with syncope as the presenting symptom.
- Patients unable to or unwilling to use the device.
Trial locations and contacts
1 site in 1 country.
About this study
In this study, we will evaluate the diagnostic yield of the new AliveCor device versus a 14 day event monitor with the use of both devices simultaneously. We will also examine by means of a questionnaire the compliance, ease of use and patient satisfaction for each device.
Hypothesis:
- The AliveCor monitor will be non-inferior to the 14 day event monitor with respect to diagnosis of the arrhythmia responsible for a patient's symptoms.
- The AliveCor monitor will have better compliance and acceptability compared to the 14 day event monitor, and thus there will be a greater number of days with recordings from the AliveCor monitor.
- Being tested
- Alivecor monitor and 14 day event monitor
- Keywords
- arrhythmia, palpitations, lightheadedness
- Medical subject headings
- Arrhythmias, Cardiac, Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alivecor monitor and 14 day event monitorDevice
Alivecor monitor and 14 day event monitor
| Study group | Role | What they receive |
|---|---|---|
| Alivecor device and event monitor | Other | Both the Alivecor device (experimental) and the standard of care (event monitor) will be provided to all patients for the duration of the study Receives: Device: Alivecor monitor and 14 day event monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of an iPhone-based Event Recorder for Arrhythmia Detection
For the primary endpoint, equivalence testing using the two one-sided test (TOST) procedure was used to compare the proportion of unpaired days in which a diagnostic recording was made with each device during the monitoring period. A difference of less than 10% between the devices on the rate of detection of arrhythmias was taken to indicate equivalence.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionMar 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Arrhythmia, Palpitations, LightheadednessStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deepika Narasimha, University at Buffalo
- Investigators
- Anne Curtis, MD, Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02005172
- Sponsor's protocol ID
- 506493-2
- Status last verified
- Apr 2023
- First submitted
- 3 Dec 2013
- Last updated
- 25 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of an iPhone-based Event Recorder for Arrhythmia Detection
- ClinicalTrials.gov ID
- NCT02005172
- Acronym / sponsor ID
- 506493-2
- Keywords
- arrhythmia, palpitations, lightheadedness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University at BuffaloUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 9 Dec 2013 (estimated)
- Results
- Posted 13 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, we will evaluate the diagnostic yield of the new AliveCor device versus a 14 day event monitor with the use of both devices simultaneously. We will also examine by means of a questionnaire the compliance, ease of use and patient satisfaction for each device.
Hypothesis:
- The AliveCor monitor will be non-inferior to the 14 day event monitor with respect to diagnosis of the arrhythmia responsible for a patient's symptoms.
- The AliveCor monitor will have better compliance and acceptability compared to the 14 day event monitor, and thus there will be a greater number of days with recordings from the AliveCor monitor.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alivecor device and event monitor | Other | Device: Alivecor monitor and 14 day event monitorBoth the Alivecor device (experimental) and the standard of care (event monitor) will be provided to all patients for the duration of the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients >18 years of age with symptoms such as palpitations or pre-syncope suggestive of arrhythmias (usually occurring less frequently than once a day) with prior non-diagnostic ECGs and/or Holter monitoring.
- Patients who own an iPhone 4, 4S or 5 device and demonstrate the capability of recording and uploading a test ECG recording at the office visit.
Key exclusion criteria (6 listed)
- Patients <18 years of age.
- Patients with a myocardial infarction (MI) within the last three months, and/or known history of sustained VT/VF.
- Patients with NYHA class IV heart failure.
- Patients with unstable angina.
- Patients with syncope as the presenting symptom.
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 monitor and 14 day event monitorAlivecor monitor and 14 day event monitor | Device | Alivecor device and event monitor |
Primary outcome
Validation of an iPhone-based Event Recorder for Arrhythmia Detection
Time frame: one year
For the primary endpoint, equivalence testing using the two one-sided test (TOST) procedure was used to compare the proportion of unpaired days in which a diagnostic recording was made with each device during the monitoring period. A difference of less than 10% between the devices on the rate of detection of arrhythmias was taken to indicate equivalence.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Anne Curtis, MD principal investigator
University at Buffalo
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 monitor and 14 day event monitor in people with Arrhythmia, Palpitations, Lightheadedness, run by University at Buffalo 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 2 inclusion and 6 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 25 May 2023. 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?
Yes. Results are posted in the registry (first posted 13 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Validation of an iPhone-based Event Recorder for Arrhythmia Detection (time frame: one year). 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 25 May 2023.