Validation of a new ECG device against standard ECG methods
Clinical Validation and Safety of the AC 12L ECG System Against a Standard of Care 12-Lead ECG (AC 12L ECG)
This study tests a new smartphone ECG device to see if it can give accurate heart readings that are as good as the traditional ECG machines.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Oklahoma Academic / other |
| Locations | 1 site (Oklahoma City, Oklahoma) |
| Trial ID | NCT05617001 on ClinicalTrials.gov |
What this trial studies
This study evaluates the accuracy and safety of the AC 12L ECG System developed by AliveCor, which is designed to record 12-lead ECGs using a smartphone interface. Participants will undergo ECG recordings with the AC 12L device while simultaneously receiving a standard 12-lead ECG from the GE CardioSoft system for comparison. The goal is to determine if the new device can provide reliable ECG data comparable to traditional methods. The study will include patients who can remain supine for the duration of the ECG recording.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who can remain supine for the ECG recording.
Not a fit: Patients with recent chest or abdominal surgery or those with limb absences that affect lead placement may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could provide a more accessible and convenient method for patients to monitor their heart health.
How similar studies have performed: While similar devices have been validated, this specific approach with the AC 12L ECG System is novel and has not yet been tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female patients 18 years or older * Ability to remain supine for a conventional 12 lead AliveCor 12L ECG recording for approximately 15 minutes Exclusion Criteria: * Open chest wounds or recent (\<30 days) surgery to the chest or abdomen * Absence of any limb that would require modification of the lead set-up
Where this trial is running
Oklahoma City, Oklahoma
- University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States (Recruiting)
Study contacts
- Principal investigator: Stavros Stavrakis, MD, PhD — University of Oklahoma
- Study coordinator: Michael Stout, RN
- Email: michael-h-stout@ouhsc.edu
- Phone: 405-271-9060
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.