- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02005172
Validation of an iPhone-based Event Recorder for Arrhythmia Detection
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
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Buffalo, New York, United States, 14226
- Dent Towers
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
one year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anne Curtis, MD, University at Buffalo
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 506493-2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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