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

NCT05327062 · XSpline S.p.A.
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Official title
CRT-DRIVE: Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment
About this study
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
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
Enrollment target: 150 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-03-06
Estimated completion: 2025-09
Last updated: 2024-10-24
Interventions
Device: CRT implantation guided by XSpline, a non-invasive electrical and venous anatomy assessment
Primary outcomes
  • Reduction of left ventricular end-systolic volume of at least 15% in 75% of CRT treated patients (6 months follow-up)
Sponsor
XSpline S.p.A. · industry
Contacts & investigators
ContactClaudia M Amatruda, PhD · contact · amatruda@xspline.com · +390471200372
InvestigatorAngelo Auricchio, MD PhD FESC · principal_investigator, Istituto Cardiocentro Ticino
All locations (13)
Rush University Medical centerNot Yet Recruiting
Chicago, Illinois, United States
The University of Chicago MedicineNot Yet Recruiting
Chicago, Illinois, United States
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
Duke University HospitalRecruiting
Durham, North Carolina, United States
Ordensklinikum Linz Elisabethinen HospitalRecruiting
Linz, Austria
Semmelweis UniversityNot Yet Recruiting
Budapest, Hungary
Fondazione IRCCS Policlinico San MatteoNot Yet Recruiting
Pavia, Pavia, Italy
University Tor VergataNot Yet Recruiting
Roma, Roma, Italy
General Hospital of BolzanoNot Yet Recruiting
Bolzano, Italy
Ospedale S. Maria del Carmine di RoveretoNot Yet Recruiting
Rovereto, Italy
Maastricht University Medical CenterNot Yet Recruiting
Maastricht, Netherlands
Univeristat de BarcelonaRecruiting
Barcelona, Spain
Istituto Cardiocentro TicinoRecruiting
Lugano, Switzerland
Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment · TrialPath