Back to Clinical Trials
N/ARecruiting

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

Sponsored by XSpline S.p.A.

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.

Where this study is enrolling (4)

Who can participate

Exclusion criteria

  • ✕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

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.