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Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment
Sponsor: XSpline S.p.A.
Summary
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.
Official title: CRT-DRIVE: Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2023-03-06
Completion Date
2025-09
Last Updated
2024-10-24
Healthy Volunteers
No
Interventions
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.
Locations (13)
Rush University Medical center
Chicago, Illinois, United States
The University of Chicago Medicine
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Duke University Hospital
Durham, North Carolina, United States
Ordensklinikum Linz Elisabethinen Hospital
Linz, Austria
Semmelweis University
Budapest, Hungary
Fondazione IRCCS Policlinico San Matteo
Pavia, Pavia, Italy
University Tor Vergata
Roma, Roma, Italy
General Hospital of Bolzano
Bolzano, Italy
Ospedale S. Maria del Carmine di Rovereto
Rovereto, Italy
Maastricht University Medical Center
Maastricht, Netherlands
Univeristat de Barcelona
Barcelona, Spain
Istituto Cardiocentro Ticino
Lugano, Switzerland