Back to resultsValidation of an iPhone-based Event Recorder for Arrhythmia Detection
Primary Purpose
Arrhythmia, Palpitations, Lightheadedness
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alivecor monitor and 14 day event monitor
Sponsored by
About this trial
This is an interventional diagnostic trial for Arrhythmia, Palpitations, Lightheadedness focused on measuring arrhythmia, palpitations, lightheadedness
Eligibility Criteria
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:
- 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.
Sites / Locations
- Dent Towers
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Alivecor device and event monitor
Arm Description
Both the Alivecor device (experimental) and the standard of care (event monitor) will be provided to all patients for the duration of the study
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02005172
Brief Title
Validation of an iPhone-based Event Recorder for Arrhythmia Detection
Official Title
Validation of an iPhone-based Event Recorder for Arrhythmia Detection
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University at Buffalo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmia, Palpitations, Lightheadedness
Keywords
arrhythmia, palpitations, lightheadedness
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Alivecor device and event monitor
Arm Type
Other
Arm Description
Both the Alivecor device (experimental) and the standard of care (event monitor) will be provided to all patients for the duration of the study
Intervention Type
Device
Intervention Name(s)
Alivecor monitor and 14 day event monitor
Intervention Description
Alivecor monitor and 14 day event monitor
Primary Outcome Measure Information:
Title
Validation of an iPhone-based Event Recorder for Arrhythmia Detection
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Curtis, MD
Organizational Affiliation
University at Buffalo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dent Towers
City
Buffalo
State/Province
New York
ZIP/Postal Code
14226
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Validation of an iPhone-based Event Recorder for Arrhythmia Detection
We'll reach out to this number within 24 hrs