Image Supported Lead Placement in CRT

N/AActive Not RecruitingNCT05053568

UMC Utrecht130 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

130

Conditions

Heart Failure

Interventions

CARTBoxDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (7)

Erasmus MC

Rotterdam, South Holland, Netherlands

Amsterdam UMC

Amsterdam, Netherlands

UMC Groningen

Groningen, Netherlands

Maastricht UMC+

Maastricht, Netherlands

Outcomes

Primary Outcomes

Differences in % of patients with succesfull LV lead location

Lead location, defined as being within, adjacent, or remote from the pre-defined target.

Time frame: Direct post-CRT

Secondary Outcomes

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%.

Time frame: 6 months

Change in EQ-5D-5L

A quality of life questionnaire

Time frame: 6, 12 and 24 months

Change in Kansas City Cardiomyopathy Questionnaire

A quality of life questionnaire

Time frame: 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.

Time frame: 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.

Time frame: 24 months

Data from ClinicalTrials.gov

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