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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alivecor monitor and 14 day event monitor | Device | Alivecor monitor and 14 day event monitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | one year |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Curtis, MD | University at Buffalo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dent Towers | Buffalo | New York | 14226 | United States |
Of the 38 patients enrolled in the study (ITT Group), 33 remained in the study (PP Group) and had monitoring data for both devices.
Patients presenting with palpitations (less often than daily but more frequently than several times/month) to our outpatient cardiology clinics with a nondiagnostic previous work-up (ECG and in some cases, a Holter monitor) were eligible for the study if their symptoms warranted evaluation with external loop recorders (ELRs).
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| ID | Title | Description |
|---|---|---|
| FG000 | Per-Protocol (PP) Group | This group includes all patients who completed and complied with the study protocol (per-protocol [PP] sample). These patients completed monitoring with both the Alivecor device (experimental) and external loop recorder (standard of care). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Thirty-eight patients were enrolled and analyzed for baseline characteristics in the intention-to-treat group. Thirty-three of those participants completed the monitoring period with the Alivecor device and the ELR. This group was identified as the pre-protocol group and the baseline characteristics for this group were separately analyzed.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pre-Protocol (PP) Group | This group includes all patients who completed and complied with the study protocol (per-protocol [PP] sample). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intention to treat analysis | Posted | Number | participants | one year |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Alivecor Device and Event Monitor | Both the Alivecor device (experimental) and the standard of care (event monitor) will be provided to all patients for the duration of the study Alivecor monitor and 14 day event monitor: Alivecor monitor and 14 day event monitor |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deepika Narasimha | University at Buffalo | deepikan@buffalo.edu |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D004244 | Dizziness |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Educational level | Count of Participants | Participants |
|
| Symptoms | Number | participants |
|
| CAD/Previous MI | Number | participants |
|
| Hypertension | Number | participants |
|
| Recent ablation | Number | participants |
|
| Antiarrhythmic drugs | Number | participants |
|
Event monitor or ELR used for 14 days
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
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| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |