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ACTIVE NOT RECRUITING
NCT05053568
NA

Image Supported Lead Placement in CRT

Sponsor: UMC Utrecht

View on ClinicalTrials.gov

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.

Official title: Advanced Image Supported Lead Placement in Cardiac Resynchronization Therapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

130

Start Date

2021-02-08

Completion Date

2025-10

Last Updated

2025-04-01

Healthy Volunteers

No

Conditions

Interventions

DEVICE

CARTBox

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.

Locations (7)

Erasmus MC

Rotterdam, South 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