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Cardiac Resynchronization Therapy Guided by XSpline

This study is looking at a new way to guide Cardiac Resynchronization Therapy (CRT) implantation, a treatment for chronic heart failure and left bundle-branch block (a heart electrical problem). It uses a non-invasive (not entering the body) assessment called XSpline to create a detailed map of your heart's electrical activity and veins. This map helps doctors place the CRT device more precisely. The study aims to see if at least 75% of patients who receive CRT guided by XSpline will have a 15% or more reduction in the size of their left ventricle (a heart chamber) after 6 months. You may be able to join if you are 18 or older and meet specific guidelines for CRT. The current recruitment status is unclear.

Study design
This is a multicenter controlled study planning to enroll 150 participants. It is an interventional study, meaning participants will receive a specific treatment.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 6 months to measure the reduction in left ventricular end-systolic volume.

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NCT05327062

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

Recruiting
NAAges 18+InterventionalDiagnostic
XSpline S.p.A.
~150 participants
Updated 2024-10-24 on ClinicalTrials.gov
What's tested:CRT implantation guided by XSpline, a non-invasive electrical and venous anatomy assessment

At a glance

Recruiting sites
5 of 13 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Reduction of left ventricular end-systolic volume of at least 15% in 75% of CRT treated patients
Measured over 6 months follow-up

Conditions

Cardiac Resynchronization Therapy
Chronic Heart Failure
Left Bundle-Branch Block

Explore related trials

Heart FailureLeft bundle branch block

NCT05327062

Where you'd take part

This study runs at 13 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Duke University Hospital

    Durham, North Carolinastudy coordinator listed

    Recruiting

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, Pavia, Italystudy coordinator listed

    Not yet recruiting

  • General Hospital of Bolzano

    Bolzano, Italystudy coordinator listed

    Not yet recruiting

  • Istituto Cardiocentro Ticino

    Lugano, Switzerlandstudy coordinator listed

    Recruiting

  • Maastricht University Medical Center

    Maastricht, Netherlandsstudy coordinator listed

    Not yet recruiting

  • Massachusetts General Hospital

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • Ordensklinikum Linz Elisabethinen Hospital

    Linz, Austriastudy coordinator listed

    Recruiting

  • Ospedale S. Maria del Carmine di Rovereto

    Rovereto, Italystudy coordinator listed

    Not yet recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Angelo Auricchio, MD PhD FESC · PRINCIPAL_INVESTIGATOR · Istituto Cardiocentro Ticino

Who to contact

Claudia M Amatruda, PhD
[email protected]
+390471200372
Email the study team

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Eligibility criteria

Exclusion

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

What this trial measures

  • Reduction of left ventricular end-systolic volume of at least 15% in 75% of CRT treated patients6 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