Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment (CRT-DRIVE)

XSpline

Status: Enrolling

Conditions: Left Bundle-Branch Block; Chronic Heart Failure; Cardiac Resynchronization Therapy

Treatments: Device: CRT implantation guided by XSpline, a non-invasive electrical and venous anatomy assessment

Study type: Interventional

Funder types: Industry

Identifiers

NCT05327062

CRT-DRIVE_01

Details and patient eligibility

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

CRT implantation guided by XSpline

Experimental group

Description:

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.

Treatment:

Device: CRT implantation guided by XSpline, a non-invasive electrical and venous anatomy assessment