Key result
Continuous monitoring using an insertable cardiac monitor will be evaluated over 18 months to assess the incidence of non-sustained ventricular tachycardia and atrial fibrillation in 30 patients with HCM.
Why the study?
Does an insertable cardiac monitor effectively assess the incidence of non-sustained ventricular tachycardia and atrial fibrillation over 18 months in adult patients with hypertrophic cardiomyopathy?
Observational (n=30)
Does an insertable cardiac monitor effectively assess the incidence of non-sustained ventricular tachycardia and atrial fibrillation over 18 months in adult patients with hypertrophic cardiomyopathy?
The ELUCIDATE HCM study is designed to evaluate the true incidence and burden of arrhythmias using an insertable cardiac monitor over 18 months in patients with hypertrophic cardiomyopathy.
ICM monitoring in 30 HCM patients may quantify arrhythmia burden; leaves open whether routine use improves outcomes.
INTRODUCTION: Hypertrophic cardiomyopathy (HCM) is a heterogeneous disease associated with sudden cardiac death (SCD) mainly due to ventricular tachycardia (VT) or fibrillation even though life-threatening bradycardia occurs. Risk stratification takes several variables into consideration including non-sustained VT (NSVT). An implantable cardioverter defibrillator effectively prevents SCD.Atrial fibrillation (AF) is common among patients with HCM and warrants anticoagulation even without conventional risk factors according to European guidelines. Routinely, the evaluation of arrhythmias using a 48-hour ambulatory external monitor takes place every 6-24 months if patients do not report palpitations. The remaining time the potential burden arrhythmia is unknown. Therefore, the aim of the present study is to assess NSVT and AF incidence during 18 months by an insertable cardiac monitor (ICM). METHODS: Adult patients, aged 18-65 years, with a validated diagnosis of HCM are eligible for the study. The study sample is planned to include 30 patients. A Confirm Rx is implanted at the level of the fourth rib on the left side subcutaneously after local anaesthesia. The application for monitoring is installed in the patients' smartphone and symptoms registered by the patient activation and VT detection programmed as 160 bpm during ≥8 intervals. An AF episode is recorded based on ≥2 min duration. Bradycardia is recorded at ≤40 bpm or pause ≥3.0 s. The patients are followed during 18 months before explant. ETHICS AND DISSEMINATION: The study was approved by The Regional Ethical Committee in Umeå (protocol number 2017/13-31). The study protocol, including variables and prespecified research questions, the study was registered at Clinical Trial Registration NCT03259113. Each patient is informed about the study in both oral and written form by a physician and included after written consent.
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Magnusson et al. (2017) conducted an observational in Hypertrophic cardiomyopathy (n=30). Insertable cardiac monitor (Confirm Rx) was evaluated on Incidence of non-sustained ventricular tachycardia (NSVT) and atrial fibrillation (AF). Continuous monitoring using an insertable cardiac monitor will be evaluated over 18 months to assess the incidence of non-sustained ventricular tachycardia and atrial fibrillation in 30 patients with HCM.
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