Biotronik has announced first patient enrolment in the company’s BIO.Detect HF II study. The study’s goal is to investigate the clinical relevance of the intracardiac impedance (ICI) sensing technology and its ability to assess haemodynamic parameters.
The ICI technology is incorporated in the company’s new cardiac resynchronisation therapy defibrillators (CRT-D) which includes the Lumax 740 HF-T. The ICI sensor evaluates changes in impedance during the cycle of the heart and is expected to be a useful surrogate for several left ventricular (LV) haemodynamic parameters.
The new technology is set to improve cardiac resynchronisation therapy for heart failure patients. As the ICI technology is integrated into the device and will work with traditional leads, patients do not need to undergo any further complex or time consuming invasive procedures. Once clinically proven, this ICI sensor will form the basis for several unique algorithms for highly specific detection of worsening heart failure, automatic AV- and VV-delay optimisation and intraoperative selection of optimal left ventricular lead placement.
“The BIO.Detect HF II study will evaluate whether haemodynamic changes can be used to inform physicians about changes in cardiac output-and whether these measurements can be put to work to optimise resynchronisation therapy,” said Peter Søgaard, Aalborg University, Denmark, coordinating clinical investigator for the study. “These much anticipated study results will form a basis for the development of an algorithm for therapy optimisation for cardiac resynchronisation therapy defibrillator patients.”
The multicentre, international, non-randomised interventional study includes 15 European investigational sites and is open to 60 patients. Each patient is implanted with a Lumax 740 HF-T device and is then tracked daily with Biotronik Home Monitoring. The ICI data will be compared with data obtained by validated echocardiographic reference methods.
“Currently there is no reliable test that gives physicians sufficient time to intervene before a patient’s status becomes critical and the situation may result in acute hospitalisation,” said Klaus-Jürgen Gutleben, Heart and Diabetes Center, Bad Oeynhausen, Germany. “A continuous measurement of left ventricular volume would provide important information about disease progression and could be used to monitor heart failure and the optimisation of CRT therapy.”