150
Participants
Start Date
March 6, 2023
Primary Completion Date
March 31, 2025
Study Completion Date
September 30, 2025
CRT implantation guided by XSpline, a non-invasive electrical and venous anatomy assessment
"The following information and data will be obtained from the routine clinical work up of the patients: Patient demographics, cardiovascular medical history, and clinical examination; 12-lead ECG; Standard echocardiography; Computed tomography angiography for visualization of atria, ventricle, and coronary sinus.~Imaging data will be transferred to the cloud-based web-platform using a dedicated software provided by study sponsor. Data processing includes evaluating the quality of the data and calculation of various anatomical and electrical parameters, and identification of the target zone as a point in the target vein closest to the latest activation zone.~LV-lead location is based on the information provided by the dedicated software followed by visual X-ray based verification of anatomically suitable/most desirable position.~The patient will undergo CRT device implantation according to local protocols."
RECRUITING
Duke University Hospital, Durham
NOT_YET_RECRUITING
Rush University Medical center, Chicago
NOT_YET_RECRUITING
The University of Chicago Medicine, Chicago
RECRUITING
Massachusetts General Hospital, Boston
RECRUITING
Ordensklinikum Linz Elisabethinen Hospital, Linz
NOT_YET_RECRUITING
Semmelweis University, Budapest
NOT_YET_RECRUITING
Fondazione IRCCS Policlinico San Matteo, Pavia
NOT_YET_RECRUITING
University Tor Vergata, Roma
NOT_YET_RECRUITING
General Hospital of Bolzano, Bolzano
NOT_YET_RECRUITING
Ospedale S. Maria del Carmine di Rovereto, Rovereto
NOT_YET_RECRUITING
Maastricht University Medical Center, Maastricht
RECRUITING
Univeristat de Barcelona, Barcelona
RECRUITING
Istituto Cardiocentro Ticino, Lugano
XSpline S.p.A.
INDUSTRY