The efficacy of single-lead implantable cardioverter-defibrillator with atrial sensing dipole to detect atrial fibrillation and to reduce inappropriate therapy according to atrial sensing ON or OFF: Rationale and design of the SMART-CONTROL study, a prospective multicenter randomized trial

• Published in: The American heart journal 2022-09, Vol.251, p.25-31
• Main Authors: Gwag, Hye Bin, Kim, Hye Ree, Park, Seung-Jung, Kim, Juwon, Chung, Tae Wan, Choi, Ji-Hoon, Kim, Ju Youn, Park, Kyoung-Min, On, Young Keun, Kim, June Soo
• Format: Article
• Language: English
• Subjects: Cardiac arrhythmia; Cardiovascular diseases; Congestive heart failure; Data collection; Defibrillators; Dipoles; Electrocardiography; Enrollments; Fibrillation; Heart failure; Mortality; Patients; Questioning; Stability analysis; Tachyarrhythmia; Therapy; Thromboembolism; Transplants & implants; Ventricle
• ISSN: 0002-8703; 1097-6744
• DOI: 10.1016/j.ahj.2022.05.008

Few studies have compared the efficacy of single-lead implantable cardioverter-defibrillator (ICD) with atrial sensing dipole (VDD-ICD) and conventional single-chamber ICD from the aspect of atrial fibrillation (AF) detection or inappropriate ICD therapy reduction. In the SMART-CONTROL trial (NCT03932604), we primarily aim to investigate whether the atrial sensing capability of VDD-ICD is useful in AF detection and inappropriate therapy reduction by randomly activating or deactivating the atrial sensing function. This study was designed as a prospective, multicenter, open-label, randomized trial to enroll 640 patients with no history of clinical AF or rhythm control for AF within 1 year who were undergoing the implantation of VDD-ICD system. Patients are assigned randomly to atrial sensing “ON” or “OFF” group, with crossover allowed during follow-up. The coprimary outcomes are the incidence of AF detection and inappropriate ICD therapy over a 2-year follow-up period. The secondary outcomes include non-AF atrial tachyarrhythmia, ventricular tachyarrhythmia with or without ICD therapy, thromboembolic events, bleeding, heart failure hospitalization, mortality, a composite of adverse cardiovascular events, and long-term atrial sensing stability or variability. We expect that this trial can evaluate the efficacy of a single-lead ICD system on various clinical outcomes including AF detection and inappropriate therapy reduction, and ultimately provide guidance to selection of ICD system.