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NCT05053243 · ClinicalTrials.gov registry record · NA
Clinical Validation of the AliveCor Kardia 12L and 6L Devices
A NA study, sponsored by University of Oklahoma.
- Completed
- Registry status
- NA
- Development phase
- 221
- Enrollment target
NCT05053243: Completed NA study, sponsored by University of Oklahoma.
NCT05053243 is a NA study that has completed, run by University of Oklahoma. The registered enrollment target is 221 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05053243, a NA study, has completed, sponsored by University of Oklahoma.
- COMPLETED
- Registry status
- NA
- Development phase
- 221 participants
- Enrollment target
Study Summary
AliveCor (www.alivecor.com) has developed an ECG device (KardiaMobile) that interfaces with iOS and Android smartphones and tablets. This ECG consists of a lightweight hardware case with two metal electrodes that can snap onto the back of the phone and a software application. By holding the right finger(s) on the right electrode and the left finger(s) on the left electrode, an electrical circuit is completed and a lead-I, 30 second rhythm strip is created. KardiaMobile and a newer device, KardiaMobile 6L, were approved by FDA for ECG rhythm recording. Recently, AliveCor developed two new devices: Kardia 12L and Kardia 6L to record 12- lead and 6-lead ECGs, respectively. However, the data generated from the two new devices have not yet been validated for accuracy. The purpose of this study is to evaluate the accuracy of the ECGs recorded by AliveCor Kardia 12L and 6L devices. This will be compared to simultaneous standard of-care 12-lead ECG recordings. The ECGs will be analyzed for accuracy and statistical difference using root-mean-square error and cross correlation between the median beats.
Primary Outcome
Quantitative analysis on QRS width will be performed on the median-beat ECGs derived from the recorded ECGs from both devices as well as 12-lead ECG for each study participant
Interventions
- DEVICE Kardia 12L
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 221 participants |
| Start Date | 2021-09-27 |
| Est. Completion | 2023-05-24 |
| Phase | NA |
What the finished NCT05053243 record still lists
NCT05053243 is an interventional study that assigns participants to a tested intervention. The registered 221 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 1 intervention - of which Kardia 12L is the first listed.
NCT05053243 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05053243 about?
NCT05053243 is a clinical study titled "Clinical Validation of the AliveCor Kardia 12L and 6L Devices". AliveCor (www.alivecor.com) has developed an ECG device (KardiaMobile) that interfaces with iOS and Android smartphones and tablets. This ECG consists of a lightweight hardware case with two metal electrodes that can snap onto the back of the phone and a software application. By holding the right fi...
What is the current status of trial NCT05053243?
This trial is currently completed. It is a NA study. The enrollment target is 221 participants. The study started on 2021-09-27. Estimated completion is 2023-05-24.
What interventions are being tested in trial NCT05053243?
The interventions under investigation include: Kardia 12L (DEVICE).
Who is sponsoring clinical trial NCT05053243?
This trial is sponsored by University of Oklahoma, which has 358 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05053243's enrollment target sits among peer trials
221 481st of 2000 higher than 1,520 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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