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

NARecruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

March 6, 2023

Primary Completion Date

March 31, 2025

Study Completion Date

September 30, 2025

Conditions
Cardiac Resynchronization TherapyChronic Heart FailureLeft Bundle-Branch Block
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."

Trial Locations (13)

27710

RECRUITING

Duke University Hospital, Durham

60637

NOT_YET_RECRUITING

Rush University Medical center, Chicago

NOT_YET_RECRUITING

The University of Chicago Medicine, Chicago

02114

RECRUITING

Massachusetts General Hospital, Boston

Unknown

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

All Listed Sponsors
lead

XSpline S.p.A.

INDUSTRY