Arrhythmia, Palpitations, Lightheadedness Clinical Trial
Official title:
Validation of an iPhone-based Event Recorder for Arrhythmia Detection
| NCT number | NCT02005172 |
| Other study ID # | 506493-2 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | November 2013 |
| Est. completion date | May 2016 |
| Verified date | April 2023 |
| Source | University at Buffalo |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 38 |
| Est. completion date | May 2016 |
| Est. primary completion date | March 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Dent Towers | Buffalo | New York |
| Lead Sponsor | Collaborator |
|---|---|
| University at Buffalo |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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. | one year |