NCT05327062 Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment
| NCT ID | NCT05327062 |
| Status | Recruiting |
| Phase | — |
| Sponsor | XSpline S.p.A. |
| Condition | Cardiac Resynchronization Therapy |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2023-03-06 |
| Primary Completion | 2025-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2023-03-06 with a primary completion date of 2025-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Angelo Auricchio, MD PhD FESC
PRINCIPAL INVESTIGATOR
Istituto Cardiocentro Ticino
Frequently Asked Questions
Who can join the NCT05327062 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiac Resynchronization Therapy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05327062 currently recruiting?
Yes, NCT05327062 is actively recruiting participants. Contact the research team at amatruda@xspline.com for enrollment information.
Where is the NCT05327062 trial being conducted?
This trial is being conducted at Chicago, United States, Chicago, United States, Boston, United States, Durham, United States and 9 additional locations.
Who is sponsoring the NCT05327062 clinical trial?
NCT05327062 is sponsored by XSpline S.p.A.. The principal investigator is Angelo Auricchio, MD PhD FESC at Istituto Cardiocentro Ticino. The trial plans to enroll 150 participants.