J&J’s Janssen, iRhythm report data from ECG patch study
Johnson & Johnson‘s (NYSE:JNJ) Janssen Pharmaceuticals touted late-breaking results from a home-based clinical trial showing that a wearable contiuous ECG patch can diagnose people with asymptomatic atrial fibrillation earlier and more efficiently compared to routine care.
The 3,476-patient study evaluated 1,738 participants wearing the ECG patch for a four-week period, divided into two two-week intervals, matching each patient with an ECG patch to two patients in the observational control group. Patients in the control group received routine care, including regular visits to a primary care physician.
The study’s primary endpoint was the time to first diagnosis of AFib. After one year, 6.3% of patients wearing the ECG patch were newly diagnosed with AFib compared to 2.3% in the control group. 65 of the 109 patients diagnosed with AFib in the ECG patch group were diagnosed using the patch, while the other 44 patients were diagnosed in the clinic.
Most of the patients diagnosed with AFib had a relatively low burden of the condition, according to Janssen. The company also reported that 70 patients in the ECG patch group were found to have potentially actionable arrhythmias.
“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 enrollment and participant engagement,” Dr. Eric Topol, founder & director of STSI, said in prepared remarks. “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.”
“We are honored to team up with STSI, Aetna and iRhythm Technologies on this groundbreaking study,” Dr. JoAnne Foody, head of Janssen Pharmaceuticals’ cardiovascular therapies business, added. “By leading innovative real-world research to help increase the early detection of AFib, we are encouraging more informed patient and physician discussions.”
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