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NCT Number: NCT05327062

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

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.

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Key information

Conditions

Cardiac Resynchronization Therapy Arrhythmias, Cardiac Bundle-Branch Block Cardiac Conduction System Disease Cardiovascular Diseases Chronic Heart Failure Heart Block Heart Diseases Left Bundle-Branch Block Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ordensklinikum Linz Elisabethinen Hospital, Linz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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 outcomes

  1. Feasibility of systematic use of XSpline platform for CRT implantation

    Time frame: 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)

  2. CRT procedural time difference

    Time frame: 6 months follow-up

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

  3. Total X-ray exposure time difference

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Claudia M Amatruda, PhD

CONTACT

[email protected]

+390471200372

Sponsors and collaborators

Lead sponsor

XSpline S.p.A.

Industry

Registry information

Official study title

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

Acronym: CRT-DRIVE

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 14, 2022
Registry last updated
Oct 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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