title: 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.
abstract: 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.
authors: Columbia University Medical Center, New York, NY. Electronic address: jar2@columbia.edu.
authors: James
authors: J
authors: Reiffel
authors: Southlake Regional Medical Centre, Newmarket, Ontario, Canada.
authors: Atul
authors: A
authors: Verma
authors: Mount Sinai Medical Center, New York, NY.
authors: Jonathan L
authors: JL
authors: Halperin
authors: Mayo Medical School, Rochester, MN.
authors: Bernard
authors: B
authors: Gersh
authors: Diagnostic Cardiology Group, Chattanooga, TN.
authors: Selcuk
authors: S
authors: Tombul
authors: Medtronic, Minneapolis, MN.
authors: John
authors: J
authors: Carrithers
authors: Medtronic, Minneapolis, MN.
authors: Lou
authors: L
authors: Sherfesee
authors: Lankenau Institute for Medical Research, Wynnewood, PA.
authors: Peter
authors: P
authors: Kowey
mesh_terms: D001281:Atrial Fibrillation / Q000175:diagnosis* / Q000453:epidemiology; D004867:Equipment Design; D006801:Humans; D018670:Monitoring, Ambulatory / Q000295:instrumentation / Q000379:methods*; D015337:Multicenter Studies as Topic; D011446:Prospective Studies; D019736:Prostheses and Implants; D012107:Research Design; D018570:Risk Assessment