Image Supported Lead Placement in CRT

Not Applicable

Active, not recruiting

• Conditions: Heart Failure
• Interventions: Device: CARTBox

• Registration Number: NCT05053568
• Lead Sponsor: UMC Utrecht

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-08
• Study First Submitted: 2021-08-27
• Study First Submitted QC: 2021-09-13
• Study First Posted: 2021-09-22
• Primary Completion: 2023-10-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-04-01
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 130

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	CARTBox	Live visualised, fluoroscopy-fused, image-guided, left ventricular lead placement on the basis of avoiding scar and targeting late mechanically activated segments.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in Kansas City Cardiomyopathy Questionnaire	6, 12 and 24 months	A quality of life questionnaire
Change in EQ-5D-5L	6, 12 and 24 months	A quality of life questionnaire
Change in reverse remodelling and volumetric response	6 months	Measured as the relative decrease in LV end-systolic volume, indexed to body surface area (LVESVi). Response defined as LVESVi-reduction ≥ 15%.
Health Technology Assessment	24 months	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.
Change in CRT response score	12 months	A hierarchical clinical endpoints, combining relative LVESVi-decrease, change in New York Heart Association class, and death at 12 month follow-up.

Trial Locations

Locations (7)

Erasmus MC; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands

Amsterdam UMC; 🇳🇱 Amsterdam, Netherlands

UMC Groningen; 🇳🇱 Groningen, Netherlands

Maastricht UMC+; 🇳🇱 Maastricht, Netherlands

St. Antonius Nieuwegein; 🇳🇱 Nieuwegein, Netherlands

UMC Utrecht; 🇳🇱 Utrecht, Netherlands

Isala Zwolle; 🇳🇱 Zwolle, Netherlands