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

ConditionsCardiac Resynchronization Therapy Chronic Heart Failure Left Bundle-Branch Block

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorXSpline S.p.A.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

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.

Treatment groups

150 Participants

are divided into 1 treatment group

Group A: CRT implantation guided by XSplineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Reduction of left ventricular end-systolic volume of at least 15% in 75% of CRT treated patients

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

Time frame

6 months follow-up

Secondary outcomes

Feasibility of systematic use of XSpline platform for CRT implantation

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)

Time frame

6 months follow-up

CRT procedural time difference

Evaluate the change in CRT procedural time by comparing with standard approach as found in literature, time in minutes

Time frame

6 months follow-up

Total X-ray exposure time difference

Evaluate the change in total X-ray exposure time by comparing with standard approach as found in literature, time in minutes

Time frame

6 months follow-up