Janssen Pharmaceutical has announced encouraging one-year results from the mSToPS clinical trial that evaluated the wearable continuous electrocardiogram (ECG) monitoring iRhythm ZIO XT Patch to identify asymptomatic atrial fibrillation (AFib).
The single-use, 14-day wearable sensor is designed to monitor and retain data from the continuous ECG of the user for up to two weeks.
Trial data revealed that the patch can identify people with AFib earlier and more efficiently than standard care. The home-based trial was conducted in alliance with Scripps Translational Science Institute (STSI), Aetna and iRhythm Technologies.
STSI founder and director Eric Topol said: “We hope that a digital infrastructure will help reimagine how clinical trials can be performed and that this study will be a useful template for remote enrolment and participant engagement.
“We will have follow-up data to determine if earlier detection of AFib translates into long-term clinical benefits, including reduction of stroke and potential cost savings.”
The trial included 1,738 subjects in one arm who used the wearable patch for continuous ECG monitoring over four weeks, while another observational control arm recruited 3,476 participants given routine care such as regular visits to a physician.
The trial’s primary endpoint was the time it took for the first diagnosis of AFib.
A total of 109 patients wearing the monitoring patch were diagnosed with AFib compared with 81 in the control group. In addition, 70 patients in the patch group were observed to have potentially actionable arrhythmias.
It was further revealed that 5.4% of patients with the ECG monitoring patch initiated anticoagulant treatment compared with 3.4% in the control arm.