Recruiting

Cardiac Resynchronization Therapy

Sponsor:

XSpline S.p.A.

Code:

NCT05327062

Conditions

Cardiac Resynchronization Therapy

Chronic Heart Failure

Left Bundle-Branch Block

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

Brief 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.

Conditions

Cardiac Resynchronization Therapy

Chronic Heart Failure

Left Bundle-Branch Block

Study ID

NCT05327062

Start date

Mar 6, 2023

Status verified date

Oct, 2024

Completion date

Sep, 2025

Anticipated

Primary completion date

Mar, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

150 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: CRT implantation guided by XSpline

The sample size estimation was based on two recent studies including CRT patients with similar clinical and demographic characteristics as in this study: the SMART-MSP and the SMART CRT. The SMART-MSP is a prospective, observational study that enrolled 584 CRT recipients at 52 US sites. In a typical modern CRT population, 75% of patients had a reduction of the end-systolic volume ≥ 15% at 6-month follow-up. The SMART-CRT study enrolled 699 CRT patients randomized to a treatment arm and a control group. At 6-months follow-up, a reduction of LVESV ≥15% was achieved for 67.7% of the patients in the control group and for 74.8% of those in the treatment arm. Therefore, it is assumed that in a modern CRT population at least 70% of the patients will have a reduction of the LVESV ≥15% of the baseline value at 6-months after CRT implantation. To demonstrate that this proportion of patients can be equally achieved with the approach tested in this study at least 150 patients need to be included.

Interventions

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.

Primary outcome measure

  • Reduction of left ventricular end-systolic volume of at least 15% in 75% of CRT treated patients [ Time Frame: 6 months follow-up ]

Central Contacts and Locations

Central contacts

Claudia M Amatruda, PhD

+390471200372amatruda@xspline.com

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Jag Singh

JSINGH@mgh.harvard.edu

Duke University Hospital

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Daniel Friedman

daniel.friedman@duke.edu

More Information

Sponsor

XSpline S.p.A.

Last update posted

Oct 24, 2024

Last verified

Oct, 2024

Keywords

  • Non-invasive activation mapping
  • Coronary Sinus

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by XSpline S.p.A. on 2024-10-24.