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Clinical Trials in Austria / NCT05327062
Recruiting Not applicable

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

NCT05327062 · tracked via the Priya Life Science Austria tracker
Sponsor
XSpline S.p.A
Phase
Not applicable
Started
2023-03-06
Last updated
2024-10-24

Condition(s) studied

Cardiac Resynchronization TherapyChronic Heart FailureLeft Bundle-Branch Block

Investigational drug(s) / intervention(s)

CRT implantation guided by XSpline, a non-invasive electrical and venous anatomy assessment

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Eligible subjects shall meet all following criteria: * Appropriately signed and dated informed consent. * Age ≥18 years at time of consent. * CRT indication according to the 2021 ESC guidelines on cardiac pacing and CRT (class I and IIA indication in patients with LBBB QRS morphology) or to 2017 AHA/ACC/HFSA guidelines (COR I). * Sinus rhythm * QRS duration ≥130 ms * Left bundle branch block * Left ventricular ejection fraction ≤35% * Symptomatic heart failure NYHA class ≥ II * Documented stable medical treatment for at least 6 months * No cardiovascular intervention during the last 6 month Exclusion Criteria are: * History of persistent or permanent atrial fibrillation * Previous pacemaker or ICD implantation * Indication to pacing due to bradycardia * Patients considered for His bundle pacing or cardiac conduction pacing * Patients with unstable angina * Subject experienced a recent myocardial infarction, within 40 days prior to enrollment * Subject underwent coronary artery bypass graft or valve surgery, within 90 days prior to enrollment * Subject is post heart transplantation, or is actively listed on the transplantation list, or has reasonable probability (per investigator's discretion) of undergoing transplantation in the next year * Subject is implanted with a left ventricular assist device * Subject is on continuous or uninterrupted infusion (inotropic) therapy for heart failure * Subject has severe aortic stenosis (with a valve area of \<1.0 cm2 or significant valve disease expected to be operated within study period) * Subject has congenital heart disease * Subject has a mechanical right-sided heart valve * Subject has a life expectancy of less than one year in the opinion of the investigator * Pregnant or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth control * Subject is enrolled in one or more concurrent studies that would confound the results of this study * Patients who have contraindications to CT scanning. * Patients with chronic kidney diseases and estimated glomerular filtration rate (eGMR) calculated based on CKD-EPI 2009 \< 40 ml/min/1.73m2

Primary outcome measure(s)

  • Reduction of left ventricular end-systolic volume of at least 15% in 75% of CRT treated patients — 6 months follow-up
    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

Trial sites (13)

FacilityCityRegionStatus
Rush University Medical center Chicago Illinois Not Yet Recruiting
The University of Chicago Medicine Chicago Illinois Not Yet Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
Duke University Hospital Durham North Carolina Recruiting
Ordensklinikum Linz Elisabethinen Hospital Linz Austria Recruiting
Semmelweis University Budapest Hungary Not Yet Recruiting
Fondazione IRCCS Policlinico San Matteo Pavia Pavia Not Yet Recruiting
University Tor Vergata Roma Roma Not Yet Recruiting
General Hospital of Bolzano Bolzano Italy Not Yet Recruiting
Ospedale S. Maria del Carmine di Rovereto Rovereto Italy Not Yet Recruiting
Maastricht University Medical Center Maastricht Netherlands Not Yet Recruiting
Univeristat de Barcelona Barcelona Spain Recruiting
Istituto Cardiocentro Ticino Lugano Switzerland Recruiting

Other trials for the same condition

Assessment of the Axone Micro Quadripolar Lead for Enhanced Cardiac Resynchronization Therapy Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05327062 on ClinicalTrials.gov ↗ ← All trials in Austria