Image guided left ventricular lead implantation in cardiac resynchronisation therapy

Cardiac resynchronisation therapy (CRT) is a therapy for heart failure patients. Still 30% of patients do not benefit optimally from CRT. The implantation location of the CRT LV electrode importantly determines the therapeutic effect. A new technology, called CARTBox, is investigated, which is developed by consortium partner CART-Tech. With CARTBox the implantation location is personalised based on patient specific parameters derived from MRI imaging.

The results obtained to date support the implementation of CARTBox to increase heart function and reduce the CRT placement failure rate at least by 1/3. With this reduction, CARTBox avoids at least 1/3 of the spilling of €1.4 Billion per annum in global CRT hardware and of the treatment-associated costs of failures of >USD 250 Million in the USA alone. The project will directly result in implementation in key EU markets and later in the Americas and in Asia.

In this project a multi-center randomised clinical study is perfomed to investigate the effects of targeting the optimal target tissue for CRT LV lead placement under the guidance of CARTBox. One hundred and twenty patients will be randomised into two groups in a 1:1 fashion to be implanted with CARTBox image guidance or by a conventional method. Based on an echocardiographic measurement of LV function after 6 months the benefit of image guided LV lead implantation and the societal impact will be assessed.