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RECRUITING
NCT05327062
NA

Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment

Sponsor: XSpline S.p.A.

View on ClinicalTrials.gov

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

DEVICE

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