Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment
Recruiting · NCT05327062 · Interventional (participants receive a specific treatment) · Lead sponsor:
XSpline S.p.A.
View the official record on ClinicalTrials.gov →
Interventions studied
CRT implantation guided by XSpline, a non-invasive electrical and venous anatomy assessment
What this trial is about
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.
Who can take part
Age range
18 Years and older
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Eligibility criteria (as published)
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
Where it is running
13 locations listed across 3 US states.
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Rush University Medical center
- Chicago, Illinois, United States
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The University of Chicago Medicine
- Chicago, Illinois, United States
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Massachusetts General Hospital
- Boston, Massachusetts, United States
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Duke University Hospital
- Durham, North Carolina, United States
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Univeristat de Barcelona
- Barcelona, Spain
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General Hospital of Bolzano
- Bolzano, Italy
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Semmelweis University
- Budapest, Hungary
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Ordensklinikum Linz Elisabethinen Hospital
- Linz, Austria
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Istituto Cardiocentro Ticino
- Lugano, Switzerland
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Maastricht University Medical Center
- Maastricht, Netherlands
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Ospedale S. Maria del Carmine di Rovereto
- Rovereto, Italy
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Fondazione IRCCS Policlinico San Matteo
- Pavia, Pavia, Italy
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University Tor Vergata
- Roma, Roma, Italy
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →