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

Last updated: October 22, 2024
Sponsor: XSpline S.p.A.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Failure

Congestive Heart Failure

Treatment

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

Clinical Study ID

NCT05327062
CRT-DRIVE_01
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

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

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: CRT implantation guided by XSpline, a non-invasive electrical and venous anatomy assessment
Phase:
Study Start date:
March 06, 2023
Estimated Completion Date:
September 30, 2025

Connect with a study center

  • Ordensklinikum Linz Elisabethinen Hospital

    Linz,
    Austria

    Active - Recruiting

  • UKSH Universitätsklinikum Schleswig-Holstein

    Kiel,
    Germany

    Site Not Available

  • Semmelweis University

    Budapest,
    Hungary

    Site Not Available

  • General Hospital of Bolzano

    Bolzano,
    Italy

    Site Not Available

  • Fondazione IRCCS Policlinico San Matteo

    Pavia,
    Italy

    Site Not Available

  • University Tor Vergata

    Roma,
    Italy

    Site Not Available

  • Policlinico Casilino

    Rome,
    Italy

    Site Not Available

  • Ospedale S. Maria del Carmine di Rovereto

    Rovereto,
    Italy

    Site Not Available

  • Amsterdam University Medical Center

    Amsterdam,
    Netherlands

    Site Not Available

  • Maastricht University Medical Center

    Maastricht,
    Netherlands

    Site Not Available

  • Univeristat de Barcelona

    Barcelona,
    Spain

    Active - Recruiting

  • Istituto Cardiocentro Ticino

    Lugano,
    Switzerland

    Active - Recruiting

  • Queen Elizabeth Hospital

    Birmingham,
    United Kingdom

    Site Not Available

  • King's College Hospital

    London,
    United Kingdom

    Site Not Available

  • Rush University Medical center

    Chicago, Illinois 60637
    United States

    Site Not Available

  • The University of Chicago Medicine

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Duke University Hospital

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • Virginia Commonwealth University School of Medicine

    Richmond, Virginia 23298
    United States

    Site Not Available

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