Status:
RECRUITING
Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment
Lead Sponsor:
XSpline S.p.A.
Conditions:
Cardiac Resynchronization Therapy
Chronic Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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 in...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05327062
Start Date
March 6 2023
End Date
September 1 2025
Last Update
October 24 2024
Active Locations (13)
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1
Rush University Medical center
Chicago, Illinois, United States, 60637
2
The University of Chicago Medicine
Chicago, Illinois, United States, 60637
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
4
Duke University Hospital
Durham, North Carolina, United States, 27710