Silent atrial fibrillation in patients with an implantable cardioverter defibrillator and coronary artery disease (INDICO AF) trial: study rationale and design

BACKGROUND: Timely detection of atrial fibrillation (AF) in implantable cardioverter defibrillator (ICD) patients is clinically important for prevention of AF-related complications and inappropriate shocks. Patients with coronary artery disease (CAD) and a dual or triple chamber ICD show a high incidence of device-detected AF. Whether CAD patients with a single chamber ICD carry a similar risk for device-detected AF remains unknown. STUDY DESIGN: The INDICO AF trial is an investigator-initiated, multicentre, observational study evaluating the incidence of subclinical AF (SCAF) in CAD patients who will receive a single chamber ICD as primary prevention for sudden cardiac death (SCD). Fifty patients will receive a single chamber ICD with an integrated RR interval based AF detection algorithm. In combination with remote monitoring, rhythm data will be collected monthly. The primary endpoint is the incidence of SCAF at 1 year of follow-up; secondary endpoints include time until 10 and 20% of the patients have a first episode of SCAF. All patients in whom SCAF is detected will be invited for an outpatient visit and will receive adequate anticoagulation treatment when appropriate according to the CHA2DS2-VASc score and current guidelines. CONCLUSION: The INDICO AF trial will quantify the incidence of SCAF in patients with an ICD and CAD. The study will underscore the clinical value of SCAF detection in single chamber ICD patients using remote patient monitoring and may improve patient care. This trial is registered at trialregister.nl with trial NTR6910.