RecruitingNot ApplicableNCT05327062

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

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

Sponsor

XSpline S.p.A.

Enrollment

150 participants

Start Date

Mar 6, 2023

Study Type

INTERVENTIONAL

Conditions

Chronic Heart Failure Left Bundle-Branch Block Cardiac Resynchronization Therapy

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether detailed electrical and vein mapping of the heart can improve the placement of cardiac resynchronization therapy (CRT) devices — pacemakers that help both sides of the heart beat in sync in people with heart failure. **You may be eligible if...** - You are 18 or older - You have heart failure with a weak left ventricle (ejection fraction 35% or less) - You have a specific type of abnormal heart electrical signal called left bundle branch block - Your QRS complex on ECG is 130ms or longer - You have been on stable heart failure medication for at least 6 months **You may NOT be eligible if...** - You have persistent or permanent atrial fibrillation - You already have a pacemaker or defibrillator - You had a heart attack or heart surgery within the past 3 months - You have a heart transplant or are on a waiting list - You have severe kidney disease or are unable to have a CT scan Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECRT 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

View Full Details on ClinicalTrials.gov

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NCT05327062

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