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CLINICAL STUDIES

Head-to-Head Studies Validate Clinical Superiority

Head-to-Head Studies

Clinical proof is so important to BardyDx that it has lead three head-to-head studies.

CAM vs MCT

Continuous ECG monitoring versus mobile telemetry: A comparison of arrhythmia diagnostics in human- versus algorithmic-dependent systems.

Heart Rhythm O2 2021 1

CAM vs Zio

Comparison of two ambulatory patch ECG monitors: The benefit of the P-wave and the signal clarity.

American Heart Journal 2019 2

CAM vs Holter

Comparison of diagnostic value using a small, single channel, P-wave centric sternal ECG monitoring patch w/a standard 3-lead Holter over 24 hours.

American Heart Journal 2017 3

What healthcare professionals are saying

“I was able to pick up paroxysmal atrial fibrillation in one of my first uses of the device,

something that had been missed on prior Holters.”

-Frank Landry, M.D-

Additional Clinical Studies

P-wave centric patch monitors may reduce need for implantable monitors following cryptogenic stroke.

Circulation 2018 4 

A new sternal patch ambulatory ECG monitor differentiates outflow tract PVC from non-outflow tract PVCs.

European Cardiac Arrhythmia Society 2017 5

Sinus arrhythmias: What’s behind the plot?

Journal of Electrocardiology 2017 6

Atrial signal clarity and rhythm specificity are critical when using artificial intelligence (AI) to distinguish atrial fibrillation (AF) from rhythms that mimic AF.

Heart Rhythm Society 2020 and Heart Rhythm Congress 2020 7

P-wave centric Ambulatory ECG Monitoring in Children.

Heart Rhythm Society 2020 8

Incidence of classic atrial flutter in outpatients with paroxysmal atrial fibrillation as identified with a new P-wave centric ECG monitor Implications for the AF ablation procedure.

International Atrial Fibrillation Symposium 2017 9

Investigator Initiated Study Support Program

Bardy Diagnostics is committed to supporting investigator-initiated research efforts to expand the body of clinical evidence related to ambulatory cardiac monitoring. If you are a U.S.-based investigator and interested in the Bardy Diagnostics Investigator Initiated Study Support Program, please contact us at info@bardydx.com.

References 

1.  Willcox M, Compton S, Bardy G. Continuous ECG monitoring versus mobile telemetry: A comparison of arrhythmia diagnostics in human- versus algorithmic-dependent systems. Heart Rhythm O2, 2021; 2:6:543-559.

2.  Rho R, Vossler M, Blancher S, Poole JE. Comparison of two ambulatory patch ECG monitors: The benefit of the P-wave and the signal clarity. Am Heart J 2018; 203:109-117.

3.  Smith WM, Riddell F, Madon M, et al. Comparison of diagnostic value using a small, single channel, P-wave centric sternal ECG monitoring patch with a standard 3-lead Holter system over 24 hours. Am Heart J 2017; 185:67-73.

4. Collins J, Ortman M, Andriulli J, et al. P-Wave Centric Patch Monitors May Reduce Need for Implantable Monitors Following Cryptogenic Stroke. Circulation 2018; 138: A12894.

5. Rho R, Blancher S, McLendon K. A new sternal patch ambulatory ECG monitor differentiates outflow tract PVC from non-outflow tract PVCs. Poster presentation European Cardiac Arrhythmia Society 2017.

5. Rho R, McLendon K. Sinus arrhythmias: What’s behind the plot?. Journal of Electrocardiology 2017; 50:2:241-242.

7. Paris D, Boleyn R, Dreisbach E, et al. Atrial signal clarity and rhythm specificity are critical when using artificial intelligence (AI) to distinguish atrial fibrillation (AF) from rhythms that mimic AF. Abstract and poster presentation Heart Rhythm Congress 2020.

8. Romme A, Nguyen H. P-wave centric Ambulatory ECG Monitoring in Infants and Young Children. Poster presentation Heart Rhythm Society 2020.

9. Rho R, Blancher S, Vossler M, et al. Incidence of classic atrial flutter in outpatients with paroxysmal atrial fibrillation as identified with a new P-wave centric ECG monitor Implications for the AF ablation procedure. Poster presentation: International Atrial Fibrillation Symposium 2017.

DN000629 9/2022