Rationale and design of REVEAL AF: A prospective study of previously undiagnosed atrial fibrillation as documented by an insertable cardiac monitor in high-risk patients

Background Atrial fibrillation (AF) is associated with substantial morbidity and mortality. Sometimes, AF exists but is undiagnosed; yet, its risk for consequences still exists. Identifying unrecognized episodes of AF in patients without known AF but at high risk for AF is critical for guiding preventative therapy decisions. The incidence of AF in high-risk patients, understanding how physicians manage these patients once AF has been detected, and knowing which patient characteristics are most predictive of developing AF are all unknown. Methods REVEAL AF is a prospective, single-arm, open-label, multicenter, interventional study to evaluate the incidence of AF ≥6 minutes in patients without known AF but who may be at high risk for AF based on symptoms and/or demographic criteria. The Reveal Insertable Cardiac Monitor will be implanted in 400 patients, and these patients will be followed up for a minimum of 18 months to monitor for the detection of AF, up to a maximum of 30 months or until the last patient has completed their 18-month follow-up visit. Conclusions REVEAL AF will determine the incidence rate of AF lasting ≥6 minutes in patients who are at high risk for having AF. Secondary outcomes include observations regarding physician actions in response to detected AF and determination of risk markers for AF development.