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NCT02005172 · ClinicalTrials.gov registry record · NA
Validation of an iPhone-based Event Recorder for Arrhythmia Detection
A NA study of Arrhythmia, Palpitations, Lightheadedness, sponsored by University at Buffalo.
- Completed
- Registry status
- NA
- Development phase
- 38
- Enrollment target
- 1
- Study location
NCT02005172: Completed NA study of Arrhythmia, Palpitations, Lightheadedness, sponsored by University at Buffalo.
NCT02005172 is a NA study of Arrhythmia, Palpitations, Lightheadedness that has completed, run by University at Buffalo. The registered enrollment target is 38 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02005172, a NA study of Arrhythmia, Palpitations, Lightheadedness, has completed, sponsored by University at Buffalo.
- COMPLETED
- Registry status
- NA
- Development phase
- 38 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE Alivecor monitor and 14 day event monitor
Study Locations (1)
New York
- Dent Towers - Buffalo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2013-11 |
| Est. Completion | 2016-05 |
| Phase | NA |
What the finished NCT02005172 record still lists
NCT02005172 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Arrhythmia, Palpitations, Lightheadedness appearing as the primary indexed condition, and to 1 intervention - of which Alivecor monitor and 14 day event monitor is the first listed.
NCT02005172 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT02005172 about?
NCT02005172 is a clinical study titled "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: 1. The Alive...
What is the current status of trial NCT02005172?
This trial is currently completed. It is a NA study. The enrollment target is 38 participants. The study started on 2013-11. Estimated completion is 2016-05.
What conditions does trial NCT02005172 study?
This clinical trial studies the following conditions: Arrhythmia, Palpitations, Lightheadedness.
What interventions are being tested in trial NCT02005172?
The interventions under investigation include: Alivecor monitor and 14 day event monitor (DEVICE).
Who is sponsoring clinical trial NCT02005172?
This trial is sponsored by University at Buffalo, which has 67 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02005172 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02005172's enrollment target sits among peer trials
38 1538th of 2000 higher than 461 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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