Prospective observational study on predicting adverse clinical outcomes in patients with implanted defibrillating devices – a study rationale, design and principal methods

Abstract

The project “Predicting adverse clinical outcomes in patients with implanted defibrillating devices” is a prospective observational study in a group of high risk cardiac patients with already implanted either an implantable cardioverter-defibrillator (ICD) or a cardiac resynchronization therapy device with defibrillating mode (CRT-D). The primary project aim is to build predictive models for an appropriate ICD or CRT-D interventions and other adverse clinical outcomes based on clinical assessment of the cardiovascular system, general clinical status, advanced mathematical and statistical analysis of cardiovascular time series and biological signals, including pressure waveforms, ECG and cardiac impedance. Up to 600 ambulatory adult patients are scheduled to be enrolled and after the first visit they are expected to be followed-up every 6 months for a number of clinical outcomes, including antiarrhythmic therapy intervention, sudden and aborted cardiac death and total mortality. The project launched in March 2010 and is expected to end in February 2014.