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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 is a NA study that has completed, run by University of Oklahoma. The registered enrollment target is 221 participants.
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.
Interventions
- DEVICE Kardia 12L
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 221 participants |
| Start Date | 2021-09-27 |
| Est. Completion | 2023-05-24 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05053243
The ClinicalTrials.gov registry entry for NCT05053243 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 221 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Oklahoma, which has 358 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Kardia 12L is the first listed.
NCT05053243 reports 0 study locations.
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.
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