XSpline SPA / University of Linz (Austria): the first patient has been enrolled in the international multicenter clinical study for the Cardiac Resynchronization Therapy DeliveRy guided by non-Invasive electrical and VEnous anatomy assessment (CRT-DRIVE)

XSpline software in action during First enrolled CRT-DRIVE study patient. Automatic detection of the target CS vein for successful LV lead implantation based on noninvasive 3D electro-anatomical map and individual patient’s cardiac anatomy.

XSpline Cloud: First-in-class cloud platform for personalized cardiac resynchronization therapy evaluated in International Clinical Trial; first procedure performed at the Ordensklinikum Linz Elisabethinen Hospital (Austria).

(IN BRIEF) XSpline SPA, an Italian start-up company, and the Ordensklinikum Linz Elisabethinen Hospital in Austria have announced the enrollment of the first patient in a clinical study for cardiac resynchronization therapy (CRT) using non-invasive electrical and venous anatomy assessment. The study will involve 150 patients from 16 centers in the US and Europe and will be guided by XSpline Cloud, a cloud-based non-invasive cardiac panoramic mapping technology that uses artificial intelligence to provide a clear understanding of a patient’s anatomy and guide individual CRT treatment strategies. The technology also predicts outcomes and identifies the correct target zone for LV lead implantation. XSpline Cloud is an investigational device and not yet approved for commercial use.

(PRESS RELEASE) BOLZANO/ BOZEN, Italy, 19-Mar-2023 — /EuropaWire/ — XSpline SPA, a start-up company incorporated in Bolzano (Italy) and the Ordensklinikum Linz Elisabethinen Hospital in Linz (Austria) today announced the first patient enrolled in a clinical study (ClinicalTrials.govID: NCT05327062) for the cardiac resynchronization therapy (CRT) guided by non-invasive electrical and venous anatomy assessment.  The international multicenter prospective study will include 150 patients from 16 centers in the U.S. and Europe.

XSpline Cloud provides a cloud-based non-invasive cardiac panoramic mapping technology to select individual CRT treatment strategy and predict outcomes.

Fast and fully automatic Artificial Intelligence based epi- and endocardial segmentation of cardiac structures, including coronary sinus veins, provides clear understanding of individual patient’s anatomy. The electrical assessment is based on a 3D panoramic electro-anatomical map based on 12 -lead ECG only, without requiring multichannel ECG recording or any kind of body surface potential mapping. XSpline Cloud is the first system in the world with AI based identification of the correct target zone for LV lead implantation.

The cloud-platform guarantees full operability with existing clinical standards and data formats; it supports IHE profiles, HL7 FIHR, DICOM, and a broad range of ECG formats. The platform also provides embedded medical grade visualization tools, such as an integrated multimodality DICOM viewer, an ECG viewer with measurement capabilities, a high-performance 3D viewer for segmented cardiac structures and electro- anatomical maps as well as an interactive navigator for LV lead placement.

Dr. Georgios Kollias, M.D., is the principal investigator for the clinical trial in Austria and performed the first procedure on a 71-year-old patient with ESV LV of 154 ml and EF LV of 20%.

“The XSpline Cloud software provides a unique approach to selecting an individualized CRT treatment strategy. It is a comprehensive tool for successful CRT implantation that can also predict outcomes, making the implantation procedure faster, easier, and safer for the patient. We are very pleased to start using this tool in our clinic”, said Dr. Kollias.

“XSpline SPA is supported by an international R&D team of skilled clinicians, mathematicians, and biomedical engineers with the shared goal of improving patient care. We think that the real-time visualization of each patient’s individual anatomy, the precise non-invasive electro-anatomical endo- and epicardial activation map and the interactive navigator will help to increase CRT responders”, said Mr. Werner Rainer, CEO of the company.

XSpline Cloud is an investigational device and not yet approved for commercial use.

Media contact:
info@xspline.com

SOURCE: XSpline SPA, Bolzano/Bozen (Italy)