Clinical Trials Logo
  1. Home
  2. Arrhythmia
  3. NCT05053243

Clinical Validation of the AliveCor Kardia 12L and 6L Devices

Arrhythmia Clinical Trial

Official title:
Clinical Validation of the AliveCor Kardia 12L and 6L Devices

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05053243
Study type Interventional
Source University of Oklahoma
Contact
Status Completed
Phase N/A
Start date September 27, 2021
Completion date May 24, 2023
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05048602 - Drug-induced Brugada Syndrome Research Database
Completed NCT01913561 - The Use of Master Caution Garment for Continuous Monitoring for Arrhythmia Detection N/A
Completed NCT01688648 - Comparison Between Lidocaine, Dexmedetomidine, and Their Combined Infusion in Subjects Undergoing Coronary Artery Bypass Graft N/A
Completed NCT01396226 - A Multi-centre Study Comparing the Effects of AZD2927 and Placebo on the Electrical Activity in the Heart in Patients Phase 2
Terminated NCT00624520 - Mental Stress Reduction in Defibrillator Patients Phase 3
Completed NCT00756886 - Does Atorvastatin Prevent Post Operative Atrial Fibrillation After Pulmonary Resection: A Randomized Clinical Study N/A
Terminated NCT00721149 - NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation- Treatment Use Study Phase 3
Completed NCT00510029 - Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of GAP-134 Administered Intravenously Phase 1
Completed NCT00578617 - Ablation vs Drug Therapy for Atrial Fibrillation - Pilot Trial N/A
Active, not recruiting NCT00135174 - Cost-Effectiveness of Routine Follow-up Visits in Patients With a Pacemaker: The Followpace Study N/A
Completed NCT00119847 - Electrophysiological Effects of Late PCI After MI N/A
Completed NCT00035490 - Efficacy and Safety Evaluation of Azimilide Dihydrochloride in Patients With Implantable Cardioverter Defibrillators Phase 3
Completed NCT00023556 - Genetic Architecture of Heart Disease in Rural Brazil N/A
Completed NCT01076361 - Model 4968 CAPTURE EPI® STERIOD-ELUTING BIPOLAR EPICARDIAL PACING LEAD Post-approval Study N/A
Completed NCT00004560 - Public Access Defibrillation (PAD) Community Trial Phase 3
Recruiting NCT00138931 - Genetics of Cardiovascular and Neuromuscular Disease
Completed NCT01076348 - Model 4965 Post-Approval Study
Completed NCT00622453 - Arrhythmias in Myotonic Muscular Dystrophy N/A
Completed NCT00000531 - Antiarrhythmics Versus Implantable Defibrillators (AVID) Phase 3
Completed NCT00000480 - Multicenter Unsustained Tachycardia Trial (MUSTT) Phase 3