The objective of this prospective, multicenter controlled study is to assess the feasibility of a patient-tailored implantation by creating a cloud-based pre-procedural multimodality CRT-roadmap by integration of 3D images from 3D activation sequence from ECG, and coronary venous anatomy from cardiac computed tomography. This CRT-roadmap will be used to guide LV lead placement to a coronary vein in an electrically late-activated region. Study Hypothesis: At least 75% of patients undergoing a CRT implantation guided by non-invasive electrical and venous anatomy assessment (XSPLINE technology) will show a reduction of left ventricular end-systolic volume of 15% or more at 6-month evaluation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
150
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.
Rush University Medical center
Chicago, Illinois, United States
NOT_YET_RECRUITINGThe University of Chicago Medicine
Chicago, Illinois, United States
NOT_YET_RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGDuke University Hospital
Durham, North Carolina, United States
RECRUITINGOrdensklinikum Linz Elisabethinen Hospital
Linz, Austria
RECRUITINGSemmelweis University
Budapest, Hungary
NOT_YET_RECRUITINGFondazione IRCCS Policlinico San Matteo
Pavia, Pavia, Italy
NOT_YET_RECRUITINGUniversity Tor Vergata
Roma, Roma, Italy
NOT_YET_RECRUITINGGeneral Hospital of Bolzano
Bolzano, Italy
NOT_YET_RECRUITINGOspedale S. Maria del Carmine di Rovereto
Rovereto, Italy
NOT_YET_RECRUITING...and 3 more locations
Reduction of left ventricular end-systolic volume of at least 15% in 75% of CRT treated patients
Increase in efficacy of CRT using XSpline technology assessed by reduction of left ventricular end-systolic volume of at least 15% at 6-month follow-up in 75% of CRT treated patients, based on routine echo-cardiographic measurements
Time frame: 6 months follow-up
Feasibility of systematic use of XSpline platform for CRT implantation
Feasibility of systematic use of automatic cloud-based, AI-based XSpline technology through statistics on software performance (e.g. percentage of core tasks completed higher than defined thresholds)
Time frame: 6 months follow-up
CRT procedural time difference
Evaluate the change in CRT procedural time by comparing with standard approach as found in literature, time in minutes
Time frame: 6 months follow-up
Total X-ray exposure time difference
Evaluate the change in total X-ray exposure time by comparing with standard approach as found in literature, time in minutes
Time frame: 6 months follow-up
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