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

Not Applicable

Recruiting

• Conditions: Chronic Heart Failure; Cardiac Resynchronization Therapy; Left Bundle-Branch Block
• Interventions: Device: CRT implantation guided by XSpline, a non-invasive electrical and venous anatomy assessment

• Registration Number: NCT05327062
• Lead Sponsor: XSpline S.p.A.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-22
• Study First Submitted QC: 2022-04-13
• Study First Posted: 2022-04-14
• Study Start: 2023-03-06
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-22
• Last Update Posted: 2024-10-24
• Primary Completion: 2025-03
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CRT implantation guided by XSpline	CRT implantation guided by XSpline, a non-invasive electrical and venous anatomy assessment	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 Measures

Name	Time	Method
Reduction of left ventricular end-systolic volume of at least 15% in 75% of CRT treated patients	6 months follow-up	Increase in efficacy of CRT using XSpline technology assessed by reduction of left ventricular end-systolic volume of at least 15% at 6-month follow-up in 75% of CRT treated patients, based on routine echo-cardiographic measurements

Secondary Outcome Measures

Name	Time	Method
Total X-ray exposure time difference	6 months follow-up	Evaluate the change in total X-ray exposure time by comparing with standard approach as found in literature, time in minutes
CRT procedural time difference	6 months follow-up	Evaluate the change in CRT procedural time by comparing with standard approach as found in literature, time in minutes
Feasibility of systematic use of XSpline platform for CRT implantation	6 months follow-up	Feasibility of systematic use of automatic cloud-based, AI-based XSpline technology through statistics on software performance (e.g. percentage of core tasks completed higher than defined thresholds)

Trial Locations

Locations (13)

Rush University Medical center; 🇺🇸 Chicago, Illinois, United States

The University of Chicago Medicine; 🇺🇸 Chicago, Illinois, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Duke University Hospital; 🇺🇸 Durham, North Carolina, United States

Ordensklinikum Linz Elisabethinen Hospital; 🇦🇹 Linz, Austria

Semmelweis University; 🇭🇺 Budapest, Hungary

General Hospital of Bolzano; 🇮🇹 Bolzano, Italy

Fondazione IRCCS Policlinico San Matteo; 🇮🇹 Pavia, Italy

University Tor Vergata; 🇮🇹 Roma, Italy

Ospedale S. Maria del Carmine di Rovereto; 🇮🇹 Rovereto, Italy

Maastricht University Medical Center; 🇳🇱 Maastricht, Netherlands

Univeristat de Barcelona; 🇪🇸 Barcelona, Spain

Istituto Cardiocentro Ticino; 🇨🇭 Lugano, Switzerland