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

XSpline S.p.A. · NCT05327062

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
150
US sites recruiting
2
Study start
March 6, 2023
Record last updated
October 24, 2024

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

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

Conditions: Cardiac Resynchronization Therapy; Chronic Heart Failure; Left Bundle-Branch Block

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Massachusetts General Hospital

    Boston, MA 02114

    Site contact: Jag Singh · JSINGH@mgh.harvard.edu

  • Duke University Hospital

    Durham, NC 27710

    Site contact: Daniel Friedman · daniel.friedman@duke.edu

Study contacts (from the official record)

  • Claudia M Amatruda, PhD · +390471200372 · amatruda@xspline.com
All heart & blood pressure studies in Massachusetts →
Cardiac Resynchronization Therapy Delivery Guided Non-Invasive… (NCT05327062) | Bored Studies