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

• 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

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

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