Wellysis S-PAtch Cardio versus Conventional Holter Ambulatory Electrocardiographic Monitoring (The PACER Trial): Preliminary Results

Aims and Objectives: The Wellysis S-PAtch Cardio versus Conventional Holter Ambulatory Electrocardiographic Monitoring (PACER) trial consists of multiple arms. First arm is a prospective, interventional, nonrandomized, single group assignment, diagnostic substudy with intention to treat. This head-to-head trial aims to compare the diagnostic yield, or ability to detect arrhythmias – especially paroxysmal atrial fibrillation (PAF) – of the conventional Ambulatory Holter monitoring device with the Wellysis S-Patch Cardio, a novel, low-profile device consisting of a single positive bipolar lead corresponding to the standard limb lead II (n = 10). Second arm is a validation substudy of the Wellysis S-Patch Cardio device in terms of overall performance (n = 86). Background: It is widely recognized that technology can improve the health of populations in countries around the world. Smartphone technology is at the forefront of innovation in low-, middle-, and high-income countries. The smartphone technology has already improved the doctor–patient interaction, reducing costs and improving care for patients. Methodology: In the comparator arm, patients who satisfied the eligibility criteria as well as referred for ambulatory ECG monitoring were consented and enrolled prospectively to have the Holter monitor and the Wellysis S-Patch Cardio device placed simultaneously (n = 10) for 24–48 h and the incidence of clinically significant arrhythmias were compared. A feedback questionnaire was given to patients/paramedics and clinicians after completion of the study. The overall performance (patient, paramedic and clinician feedback and questionnaire derived subjective composite index of comfort, usability, interference with daily activities, adverse events, adaptability, robustness, repeatability, durability, clinical analysis, clarity of recorded signals, efficiency, accuracy, and cost-effectiveness) of Wellysis S-Patch Cardio device was compared with multi lead Holter Monitor in this head to head trial (n = 10). In the validation arm patients who satisfied the eligibility were consented and enrolled prospectively to have the Wellysis S-Patch Cardio device placed (n = 86) for 24–48 h and the incidence of clinically significant arrhythmias noted. Results: Preliminary results from the comparator arm (n = 10), Mc Nemars analysis, revealed odds ratio 1.000, 95% confidence interval 0.072–13.796, χ2 = 0.250, DF = 1, P < 0.6171; supporting the null hypothesis-Wellysis S-Patch Cardio is comparable to Holter in terms of Overall Performance (comfort, usability, interference with daily activities, adverse events, adaptability, robustness, repeatability, durability, clinical analysis, clarity of recorded signals, efficiency, accuracy, and cost-effectiveness). Conclusion: Multi lead ambulatory Holter monitoring remains the gold standard for arrhythmia detection. However, Wellysis S-Patch Cardio device has a definite complementary role in the detection of PAF in cryptogenic stroke patients.