CART-Tech has so far initiated 3 clinical studies
ADVISE-CRT-1 patient study
This was our first clinical study, providing initial clinical proof of principle for CARTBox.
In this study with 15 patients it was shown that patients who received image-guided LV lead implantation using CARTBox had their lead placed much closer to the target area compared to patients who received the lead without guidance by CARTBox (8 mm versus 26 mm, p = 0.04).
Also, all patients were classified as responders in the CARTBox group and no safety concerns were reported up till 6 months after the procedure.
Conclusion: real-time image-guided LV lead implantation is safe and feasible and may prove useful for achieving the optimal LV lead position.
This study was published in The International Journal of Cardiovascular Imaging 35:1327–1337 (2019): Multimodality imaging for real-time image-guided left ventricular lead placement during cardiac resynchronization therapy implantations.
Authors: Odette A. E. Salden, Hans T. van den Broek, Wouter M. van Everdingen, Firdaus A. A. Mohamed Hoesein, Birgitta K. Velthuis, Pieter A. Doevendans, Maarten-Jan Cramer, Anton E. Tuinenburg, Paul Leufkens, Frebus J. van Slochteren & Mathias Meine
ADVISE-2 patient study
The second clinical study is an open study in 30 patients, in which each patient receives CRT under CARTBox guidance. Three clinics are participating in this study, and after the completion of this study the participating centers will participated in a follow-up randomised study, which should lead to a demonstration of safety and efficacy of CARTBox.
ADVISE-3 patient study
Currently, CART-Tech is conducting this randomized clinical study together with several leading clinical centers, supported by ZonMw (The Netherlands Organisation for Health Research and Development):
Principle investigator: Mathias Meine, MD, PhD
Co-investigator: Philippe Wouters, MD
Antonius Ziekenhuis, Nieuwegein
Principle Investigator: Vincent van Dijk, MD, PhD
Isala Ziekenhuis, Zwolle
Principle Investigator: Peter Paul Delnoy, MD, PhD
Up to 3 clinical centers will be added in the near future.