Dr. Georgios Kollias, M.D., comments on the enrollment of the first patient in the Clinical Study for Cardiac Resynchronization Therapy Using XSpline Cloud’s Non-Invasive Technology

Dr. Georgios Kollias, M.D. comments on the enrollment of the first patient in the Clinical Study for Cardiac Resynchronization Therapy Using XSpline Cloud’s Non-Invasive Technology

(IN BRIEF) Dr. Georgios Kollias, the principal investigator for the clinical trial in Austria, expressed great satisfaction with the XSpline Cloud software, a non-invasive cardiac panoramic mapping technology designed to select individual CRT treatment strategies and predict outcomes. As the first patient enrolled in the clinical study, a 71-year-old patient with ESV LV of 154 ml and EF LV of 20%, was successfully treated with the XSpline Cloud software, Dr. Kollias lauded the system as a comprehensive tool for successful CRT implantation that makes the procedure faster, easier, and safer for patients. Dr. Kollias also commended XSpline SPA for being supported by an international R&D team with the shared goal of improving patient care. With its unique approach to selecting individualized CRT treatment strategies and real-time visualization of each patient’s individual anatomy, XSpline Cloud has the potential to increase CRT responders and positively impact patient outcomes.

(PRESS RELEASE) BOLZANO/ BOZEN, Italy, 20-Mar-2023 — /EuropaWire/ — Dr. Georgios Kollias, M.D., the principal investigator for the clinical trial in Austria, recently announced the enrollment of the first patient in the international multicenter clinical study for the Cardiac Resynchronization Therapy DeliveRy guided by non-Invasive electrical and VEnous anatomy assessment (CRT-DRIVE). This study, sponsored by XSpline SPA and conducted in collaboration with the Ordensklinikum Linz Elisabethinen Hospital in Linz, Austria, aims to evaluate the efficacy of XSpline Cloud, a cloud-based non-invasive cardiac panoramic mapping technology designed to select individual CRT treatment strategies and predict outcomes. The international multicenter prospective study will include 150 patients from 16 centers in the U.S. and Europe.

The XSpline Cloud system is based on fast and fully automatic Artificial Intelligence based epi- and endocardial segmentation of cardiac structures, including coronary sinus veins, to provide a clear understanding of the 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.

Dr. Kollias, who performed the first procedure on a 71-year-old patient with ESV LV of 154 ml and EF LV of 20%, praised XSpline Cloud software’s unique approach to selecting individualized CRT treatment strategies, predicting outcomes, and making the implantation procedure faster, easier, and safer for patients. The cloud-based platform guarantees full operability with existing clinical standards and data formats, supporting IHE profiles, HL7 FIHR, DICOM, and a broad range of ECG formats. XSpline Cloud 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.

According to Mr. Werner Rainer, CEO of XSpline SPA, the company is supported by an international R&D team of skilled clinicians, mathematicians, and biomedical engineers with the shared goal of improving patient care. XSpline Cloud’s real-time visualization of each patient’s individual anatomy and the precise non-invasive electro-anatomical endo- and epicardial activation map and the interactive navigator are expected to increase CRT responders and positively impact patient outcomes.

Here’s the original press release announcing the international multicenter clinical study for the Cardiac Resynchronization Therapy DeliveRy.

SOURCE: XSpline SPA, Bolzano/Bozen (Italy)