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Expert Consensus Statements

Steinberg, Jonathan S. et al. 2017 ISHNE-HRS expert consensus statement on ambulatory ECG and external cardiac monitoring/telemetry. Heart Rhythm. July 2017.

DOI: https://doi.org/10.1016/j.hrthm.2017.03.038

  • Patch monitors highlighted as second generation external ambulatory ECG monitoring technology.
  • Patch monitors permit long-term recording and have excellent patient acceptance.
  • Patch monitors and MCT are the most complete outpatient ECG recording and increase the likelihood for detecting AF, and can provide accurate representation of AF burden for the duration of the recording.

Carnation Ambulatory Monitor (CAM) Publications

Rho R., et al. Comparison of two ambulatory patch ECG monitors: The benefit of the P- wave and signal clarity. American Heart Journal. Manuscript Accepted Online. March 2018.

DOI: https://doi.org/10.1016/j.ahj.2018.03.022

Summary: A prospective comparison of two FDA-cleared, CE marked single-vector patch ambulatory external monitors (AEM). Primary outcome measures include ECG clarity and rhythm types diagnosed, secondary outcome measures include impact on clinical decision-making, and assessment of ease-of-use and comfort.

  • The CAM™ ECG tracings were ranked higher in clarity (29/29 ranked as “High”) compared to the Zio® XT ECG tracings (4.5/29 ranked as “High”), providing the physician reviewers a greater degree of confidence in specific rhythm diagnosis and resulting clinical decisions. P<0.001
  • The CAM patch reported more (121.7 ± 2.1) and different arrhythmias (particularly atrial tachycardia, atrial flutter, and non-sustained VT) than the Zio XT patch (86.7 ± 0.6). Both monitors performed equally in identifying atrial fibrillation. P<0.001
  • Based on physician reviewer interpretations of each CAM and Zio XT report, a different, more informed, clinical decision would have been made in 12 patients (41%) based on the CAM ECG report.

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Smith WM., 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. American Heart Journal. March 2017.

DOI: https://doi.org/10.1016/j.ahj.2016.11.006

Summary: A prospective comparative study in which 50 patients wore the CAM and Holter monitor simultaneously over a limited 24-hour time period. The CAM significantly improved rhythm diagnosis and was rated as more comfortable and preferable to wear by patients.

  • In all 50 patients, the P-wave centric patch recording system identified rhythms in 23 patients (46%) that altered management, compared to 6 Holter patients (12%), P < 0.001.
  • 48/50 (96%) of patients preferred wearing the patch monitor.
  • 44/50 (88%) of patients wearing the CAM felt that it was completely comfortable to wear, compared to 15/50 patients (30%) reporting the Holter as completely comfortable to wear.

CAM Posters

Rho R., et al. Incidence of classic atrial flutter in outpatients with paroxysmal atrial fibrillation as identified with a new P-wave centric ECG monitor. Poster Presented: International Atrial Fibrillation Symposium. January 2017. Orlando FL, USA.

Summary: This observational study examined the incidence rate of classic atrial flutter in 27 outpatients with paroxysmal atrial fibrillation (PAF), as identified while wearing the P-wave centric CAM.

  • Classic atrial flutter was identified in 19 of the 27 (70%) patients with PAF.
  • A P-wave centric ECG monitor may be helpful in detecting atrial flutter in patients who are being evaluated for AF ablation.

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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.

What Healthcare Professionals are Saying

"Almost all patient activities can be conducted unimpeded making compliance much better than any Holter or event monitor I have used previously. 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.

What Healthcare Professionals are Saying

"The simple, yet elegant and informative data presentation format allows quick assessment of the patient. Contextual data before and after an event allows me to better understand the circumstances of each arrhythmia."

- Dr. Gene Trobaugh, Cardiologist (Enumclaw, WA)