Arrhythmia, Palpitations, Lightheadedness
Conditions
Keywords
arrhythmia, palpitations, lightheadedness
Brief 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. 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. 2. 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.
Interventions
DEVICEAlivecor monitor and 14 day event monitor
Alivecor monitor and 14 day event monitor
Sponsors
University at Buffalo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
1. Patients \<18 years of age. 2. Patients with a myocardial infarction (MI) within the last three months, and/or known history of sustained VT/VF. 3. Patients with NYHA class IV heart failure. 4. Patients with unstable angina. 5. Patients with syncope as the presenting symptom. 6. Patients unable to or unwilling to use the device.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Validation of an iPhone-based Event Recorder for Arrhythmia Detection | 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. |
Countries
United States
Participant flow
Recruitment details
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).
Pre-assignment details
Of the 38 patients enrolled in the study (ITT Group), 33 remained in the study (PP Group) and had monitoring data for both devices.
Participants by arm
| Arm | Count |
|---|---|
| Pre-Protocol (PP) Group This group includes all patients who completed and complied with the study protocol (per-protocol \[PP\] sample). | 33 |
| Total | 33 |
Baseline characteristics
| Characteristic | Pre-Protocol (PP) Group |
|---|---|
| Age, Customized Age | 47.5 years STANDARD_DEVIATION 13.8 |
| Antiarrhythmic drugs | 1 participants |
| CAD/Previous MI | 4 participants |
| Educational level College | 7 Participants |
| Educational level Doctorate | 1 Participants |
| Educational level High School | 5 Participants |
| Educational level Master's | 2 Participants |
| Educational level Not reported | 18 Participants |
| Hypertension | 9 participants |
| Race/Ethnicity, Customized Race African American | 3 Participants |
| Race/Ethnicity, Customized Race White | 30 Participants |
| Recent ablation | 3 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 19 Participants |
| Symptoms Chest pain | 6 participants |
| Symptoms Lightheadedness | 11 participants |
| Symptoms Palpitations | 30 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 38 |
| serious Total, serious adverse events | 0 / 38 |
Outcome results
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.
Time frame: one year
Population: Intention to treat analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Kardia Mobile (AliveCor Device) | Validation of an iPhone-based Event Recorder for Arrhythmia Detection | Sinus arrhythmia | 5 participants |
| Kardia Mobile (AliveCor Device) | Validation of an iPhone-based Event Recorder for Arrhythmia Detection | Atrial Flutter | 0 participants |
| Kardia Mobile (AliveCor Device) | Validation of an iPhone-based Event Recorder for Arrhythmia Detection | PAC | 15 participants |
| Kardia Mobile (AliveCor Device) | Validation of an iPhone-based Event Recorder for Arrhythmia Detection | Atrial Tachycardia | 0 participants |
| Kardia Mobile (AliveCor Device) | Validation of an iPhone-based Event Recorder for Arrhythmia Detection | Sinus bradycardia | 8 participants |
| Kardia Mobile (AliveCor Device) | Validation of an iPhone-based Event Recorder for Arrhythmia Detection | SVT | 0 participants |
| Kardia Mobile (AliveCor Device) | Validation of an iPhone-based Event Recorder for Arrhythmia Detection | PVC | 11 participants |
| Kardia Mobile (AliveCor Device) | Validation of an iPhone-based Event Recorder for Arrhythmia Detection | First degree AV block | 0 participants |
| Kardia Mobile (AliveCor Device) | Validation of an iPhone-based Event Recorder for Arrhythmia Detection | Sinus pause | 0 participants |
| Kardia Mobile (AliveCor Device) | Validation of an iPhone-based Event Recorder for Arrhythmia Detection | Second degree AV block | 0 participants |
| Kardia Mobile (AliveCor Device) | Validation of an iPhone-based Event Recorder for Arrhythmia Detection | Atrial Fibrillation | 6 participants |
| Kardia Mobile (AliveCor Device) | Validation of an iPhone-based Event Recorder for Arrhythmia Detection | Third degree AV block | 0 participants |
| Kardia Mobile (AliveCor Device) | Validation of an iPhone-based Event Recorder for Arrhythmia Detection | Sinus tachycardia | 14 participants |
| External Loop Recorder (ELR/ Event Monitor) | Validation of an iPhone-based Event Recorder for Arrhythmia Detection | Third degree AV block | 0 participants |
| External Loop Recorder (ELR/ Event Monitor) | Validation of an iPhone-based Event Recorder for Arrhythmia Detection | Sinus tachycardia | 12 participants |
| External Loop Recorder (ELR/ Event Monitor) | Validation of an iPhone-based Event Recorder for Arrhythmia Detection | Sinus bradycardia | 8 participants |
| External Loop Recorder (ELR/ Event Monitor) | Validation of an iPhone-based Event Recorder for Arrhythmia Detection | Sinus arrhythmia | 2 participants |
| External Loop Recorder (ELR/ Event Monitor) | Validation of an iPhone-based Event Recorder for Arrhythmia Detection | Sinus pause | 0 participants |
| External Loop Recorder (ELR/ Event Monitor) | Validation of an iPhone-based Event Recorder for Arrhythmia Detection | PAC | 4 participants |
| External Loop Recorder (ELR/ Event Monitor) | Validation of an iPhone-based Event Recorder for Arrhythmia Detection | PVC | 11 participants |
| External Loop Recorder (ELR/ Event Monitor) | Validation of an iPhone-based Event Recorder for Arrhythmia Detection | Atrial Fibrillation | 4 participants |
| External Loop Recorder (ELR/ Event Monitor) | Validation of an iPhone-based Event Recorder for Arrhythmia Detection | Atrial Flutter | 2 participants |
| External Loop Recorder (ELR/ Event Monitor) | Validation of an iPhone-based Event Recorder for Arrhythmia Detection | Atrial Tachycardia | 0 participants |
| External Loop Recorder (ELR/ Event Monitor) | Validation of an iPhone-based Event Recorder for Arrhythmia Detection | SVT | 1 participants |
| External Loop Recorder (ELR/ Event Monitor) | Validation of an iPhone-based Event Recorder for Arrhythmia Detection | First degree AV block | 1 participants |
| External Loop Recorder (ELR/ Event Monitor) | Validation of an iPhone-based Event Recorder for Arrhythmia Detection | Second degree AV block | 0 participants |
Comparison: For the primary endpoint, equivalence testing using the two one-sided test procedure was used to compare the proportion of (unpaired) days in which a diagnostic recording was made with each device during the monitoring period. For the purpose of this study, a difference of less than 10% between devices on the rate of detection of arrhythmias was taken to indicate equivalence.