Trial Outcomes & Findings for Validation of an iPhone-based Event Recorder for Arrhythmia Detection (NCT NCT02005172)
NCT ID: NCT02005172
Last Updated: 2023-05-25
Results Overview
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.
COMPLETED
NA
38 participants
one year
2023-05-25
Participant Flow
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).
Of the 38 patients enrolled in the study (ITT Group), 33 remained in the study (PP Group) and had monitoring data for both devices.
Participant milestones
| Measure |
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).
|
|---|---|
|
Overall Study
STARTED
|
33
|
|
Overall Study
ITT
|
38
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Validation of an iPhone-based Event Recorder for Arrhythmia Detection
Baseline characteristics by cohort
| Measure |
Pre-Protocol (PP) Group
n=33 Participants
This group includes all patients who completed and complied with the study protocol (per-protocol \[PP\] sample).
|
|---|---|
|
Age, Customized
Age
|
47.5 years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · African American
|
3 Participants
n=5 Participants
|
|
Educational level
High School
|
5 Participants
n=5 Participants
|
|
Educational level
College
|
7 Participants
n=5 Participants
|
|
Educational level
Master's
|
2 Participants
n=5 Participants
|
|
Educational level
Doctorate
|
1 Participants
n=5 Participants
|
|
Educational level
Not reported
|
18 Participants
n=5 Participants
|
|
Symptoms
Palpitations
|
30 participants
n=5 Participants
|
|
Symptoms
Lightheadedness
|
11 participants
n=5 Participants
|
|
Symptoms
Chest pain
|
6 participants
n=5 Participants
|
|
CAD/Previous MI
|
4 participants
n=5 Participants
|
|
Hypertension
|
9 participants
n=5 Participants
|
|
Recent ablation
|
3 participants
n=5 Participants
|
|
Antiarrhythmic drugs
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: one yearPopulation: Intention to treat analysis
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.
Outcome measures
| Measure |
Kardia Mobile (AliveCor Device)
n=33 Participants
AliveCor (Kardia Mobile ) used for 14 days
|
External Loop Recorder (ELR/ Event Monitor)
n=33 Participants
Event monitor or ELR used for 14 days
|
|---|---|---|
|
Validation of an iPhone-based Event Recorder for Arrhythmia Detection
SVT
|
0 participants
|
1 participants
|
|
Validation of an iPhone-based Event Recorder for Arrhythmia Detection
First degree AV block
|
0 participants
|
1 participants
|
|
Validation of an iPhone-based Event Recorder for Arrhythmia Detection
Second degree AV block
|
0 participants
|
0 participants
|
|
Validation of an iPhone-based Event Recorder for Arrhythmia Detection
Sinus tachycardia
|
14 participants
|
12 participants
|
|
Validation of an iPhone-based Event Recorder for Arrhythmia Detection
Sinus bradycardia
|
8 participants
|
8 participants
|
|
Validation of an iPhone-based Event Recorder for Arrhythmia Detection
Sinus arrhythmia
|
5 participants
|
2 participants
|
|
Validation of an iPhone-based Event Recorder for Arrhythmia Detection
Sinus pause
|
0 participants
|
0 participants
|
|
Validation of an iPhone-based Event Recorder for Arrhythmia Detection
PAC
|
15 participants
|
4 participants
|
|
Validation of an iPhone-based Event Recorder for Arrhythmia Detection
PVC
|
11 participants
|
11 participants
|
|
Validation of an iPhone-based Event Recorder for Arrhythmia Detection
Atrial Fibrillation
|
6 participants
|
4 participants
|
|
Validation of an iPhone-based Event Recorder for Arrhythmia Detection
Atrial Flutter
|
0 participants
|
2 participants
|
|
Validation of an iPhone-based Event Recorder for Arrhythmia Detection
Atrial Tachycardia
|
0 participants
|
0 participants
|
|
Validation of an iPhone-based Event Recorder for Arrhythmia Detection
Third degree AV block
|
0 participants
|
0 participants
|
Adverse Events
Alivecor Device and Event Monitor
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place