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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
XSpline S.p.A.
Study ID
NCT05327062
Status
Recruiting
Apply to this trial

Conditions

  • Cardiac Resynchronization Therapy
  • Chronic Heart Failure
  • Left Bundle-Branch Block

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CRT implantation guided by XSpline, a non-invasive electrical and venous anatomy assessment — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Mar 6, 2023
Status verified
Oct 2024
Primary completion
Mar 31, 2025
Completion
Sep 30, 2025

Study Design

Enrollment
150 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

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.

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

Locations (4)

FacilityCityStateZIPSite coordinators
Rush University Medical centerChicagoIllinois60637
Parikshit S Sharma
[email protected]
Parikshit S Sharma, MD
The University of Chicago MedicineChicagoIllinois60637
Gaurav Upadhyay
[email protected]
Gaurav Upadhyay, MD
Massachusetts General HospitalBostonMassachusetts02114
William J Hucker, MD, PhD
Duke University HospitalDurhamNorth Carolina27710
Daniel Friedman
[email protected]
Daniel Friedman, MD

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Rush University Medical center· Chicago, ILThe University of Chicago Medicine· Chicago, ILMassachusetts General Hospital· Boston, MADuke University Hospital· Durham, NC

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