An interactive assistant for patients with cardiac implantable electronic devices: A study protocol of the LUCY trial

Patients with chronic heart failure (CHF) and reduced left ventricle ejection fraction benefit from cardiac resynchronization therapy (CRT) and implantable cardioverter defibrillator (ICD). However, increasing numbers of patient with CRT and ICD devices produce overload of cardiology centers where patients are admitted to ambulatory visits. This study aims to find multivariate model predicting the requirement for ambulatory follow-up of cardiac implantable electronic devices (CIEDs). The LUCY study is an observational, cohort, prospective, 2-stage trial. As equal number of patients (300) will be included in the first and the second part of the study, finally, 600 patients will be included in the study. The inclusion criteria will be: age between 18 and 90 years, CHF (New York Heart Association classes I–III) and implanted ICD or CRT at least 30 days before study inclusion. The exclusion criteria will be dementia and other conditions impeding cooperation during the study. All patients included in the study will undergo standard ambulatory visit. Primary endpoint will be defined as any ambulatory visit qualified as necessary due to patient's condition or device malfunction diagnose by the cardiologist: any change in pharmacotherapy related to patient's clinical status assessed during the visit, any change in tachyarrythmia counter or discriminator status, any change in tachyarrythmia threshold, presence of ventricular undersensing or oversensing, presence of atrial or ventricular ineffective pacing, or device's pocket infection. Secondary endpoint will be defined as any ambulatory visit qualified as necessary due to the alarm identified via Medtronic CareLink Express (MCLE): sustained or treated ventricular tachyarrythmia, any not previously diagnosed supraventricular tachyarrythmia, or elective replacement indicator. Our study is the first attempt of implementation of the machine learning and elements artificial intelligence in health care optimization of patients with CIED. The LUCY will be an open product, available for additional testing and improvement with supplementary functionalities: quality of life assessment, teleconsultation, video-streaming, automated imagine recognizing.