CRT-DRIVE: Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 150
- Locations
- 17
- Primary Endpoint
- Reduction of left ventricular end-systolic volume of at least 15% in 75% of CRT treated patients
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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
- •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
Outcomes
Primary Outcomes
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
- Total X-ray exposure time difference(6 months follow-up)
- CRT procedural time difference(6 months follow-up)
- Feasibility of systematic use of XSpline platform for CRT implantation(6 months follow-up)