Image Supported Lead Placement in CRT

Study Overview
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Brief Summary
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Cardiac resynchronization therapy (CRT) is an established pacemaker therapy for patients with symptomatic chronic heart failure, but is hampered by a non-response rate of 30-40%. Optimising left ventricular (LV) lead placement is the cornerstone of improving treatment. The optimal location for the lead is remote from scar but within segments demonstrating late electromechanical activation. The present study aims to investigate the efficacy and clinical effect of the use of real-time guided lead placement using cardiac MRI and fluoroscopy in a blinded, multicenter, randomized controlled trial.

Official Title
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Advanced Image Supported Lead Placement in Cardiac Resynchronization Therapy

Conditions
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Heart Failure

Intervention / Treatment
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* Device: CARTBox


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Heart failure with LV ejection fraction ≤ 35%; New York Heart Association class II, III, or IV (ambulatory); Optimal medical treatment that is tolerable; Left bundle branch block (LBBB) and QRS ≥ 130 ms, OR non-LBBB and QRS ≥ 150 ms. Exclusion Criteria: Pregnancy or lactation; Subjects with impaired renal function (severe renal insufficiency, GFR < 30 ml/min/1.73m2); Atrial fibrillation or atrial fibrillation during MRI Documented allergic reaction to gadolinium; Impossibility to undergo an MRI scan; Participation in another clinical study that prohibits any procedures other than standard.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Live visualised, fluoroscopy-fused, image-guided, left ventricular lead placement on the basis of avoiding scar and targeting late mechanically activated segments. | Device: CARTBox<br>* CARTBox performs analysis of cardiac MRI scans. The result is a treatment file that displays optimal targets for left ventricular lead implantation in CRT. This file will be used as an overlay with live fluoroscopy during the implantation procedure in the intervention group.<br>|
| No Intervention: Control group<br>Empirical standard-of-care left ventricular lead placement, in line with current CRT implantation guidelines with electrical guiding on the basis of Q-LV sense. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in % of patients with succesfull LV lead location | Lead location, defined as being within, adjacent, or remote from the pre-defined target. | Direct post-CRT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in reverse remodelling and volumetric response | Measured as the relative decrease in LV end-systolic volume, indexed to body surface area (LVESVi). Response defined as LVESVi-reduction ≥ 15%. | 6 months | 
| Change in EQ-5D-5L | A quality of life questionnaire | 6, 12 and 24 months | 
| Change in Kansas City Cardiomyopathy Questionnaire | A quality of life questionnaire | 6, 12 and 24 months | 
| Change in CRT response score | A hierarchical clinical endpoints, combining relative LVESVi-decrease, change in New York Heart Association class, and death at 12 month follow-up. | 12 months | 
| Health Technology Assessment | The value of image-guided lead placement will be investigated in terms of healthcare expenditure revolving heart failure care. This assesment will be based on a previously conducted preliminary economic analysis. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRI, Cardiac Resynchronization Therapy, Image-guided therapy, Lead placement