iRhythm Announces Participation in GUARD-AF Study Focused on Undiagnosed Atrial Fibrillation
iRhythm estimates that more than 10 million Americans are at high risk for a common heart rhythm disorder known as atrial fibrillation. AFib is associated with a five-fold increase in the risk of stroke, with these strokes tending to have more severe consequences.1 Approximately 25 percent of people who have an AFib-related stroke are estimated to die within one month.2 Further, some studies suggest that more than 25 percent of people who have an AFib-related stroke find out they have AFib after a stroke.3
Clinical research is already demonstrating a major unmet need in the market for earlier AFib detection. For example, at the annual meeting of the
“iRhythm is excited to participate in the GUARD-AF study with the Alliance,” said
“Through earlier AFib detection, we’re focused on helping to reduce the number of individuals who suffer an AFib-related stroke,” said
The GUARD-AF study population (n=52,000) will include men and women at least 70 years of age visiting their primary care physician for usual follow-up care, who are willing to provide consent to participate in the study. Participants will be randomized to receive Zio XT for AFib detection, or to receive usual standard medical care. The primary outcome measures will be stroke and bleeding events leading to hospitalization. A novel, pragmatic aspect of the trial is that outcome events will be ascertained from a healthcare claims database which, although subject to certain limitations, are expected to provide evidence on health outcomes associated with AFib detection intervention that may help inform future guidelines. Enrollment is expected to begin in the coming weeks. More information on the study can be found on www.clinicaltrials.gov under the identifier NCT04126486.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These statements include statements regarding clinical developments and market opportunity. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties, many of which are beyond our control, include risks described in the section entitled “Risk Factors” and elsewhere in the company’s public filings with the
iRhythm is a leading digital health care company redefining the way cardiac arrhythmias are clinically diagnosed. The company combines wearable biosensor devices worn for up to 14 days and cloud-based data analytics with powerful proprietary algorithms that distill data from millions of heartbeats into clinically actionable information. The company believes improvements in arrhythmia detection and characterization have the potential to change clinical management of patients.
1 Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, et al. Heart disease and stroke statistics—2015 update: a report from the
2 Lin HJ,
3 Freedman B, Potpara TS, Lip GY. Stroke prevention in atrial fibrillation. Lancet. 2016;388:806–817.