Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment
Purpose
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.
Conditions
- Cardiac Resynchronization Therapy
- Chronic Heart Failure
- Left Bundle-Branch Block
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- The investigation will include 9 European and 4 US investigational sites. The goal is to enroll a total number of 150 patients. It is expected about 1.5 patients per site per month over a period of maximum 8 months after site opening. The study duration is set at 12-month, 6 months for patient enrollment and 6 months of follow-up.
- Primary Purpose
- Diagnostic
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental CRT implantation guided by XSpline |
The sample size estimation was based on two recent studies including CRT patients with similar clinical and demographic characteristics as in this study: the SMART-MSP and the SMART CRT. The SMART-MSP is a prospective, observational study that enrolled 584 CRT recipients at 52 US sites. In a typical modern CRT population, 75% of patients had a reduction of the end-systolic volume ≥ 15% at 6-month follow-up. The SMART-CRT study enrolled 699 CRT patients randomized to a treatment arm and a control group. At 6-months follow-up, a reduction of LVESV ≥15% was achieved for 67.7% of the patients in the control group and for 74.8% of those in the treatment arm. Therefore, it is assumed that in a modern CRT population at least 70% of the patients will have a reduction of the LVESV ≥15% of the baseline value at 6-months after CRT implantation. To demonstrate that this proportion of patients can be equally achieved with the approach tested in this study at least 150 patients need to be included. |
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Recruiting Locations
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- XSpline S.p.A.