NCT05053568

Image Supported Lead Placement in CRT

Advanced Image Supported Lead Placement in Cardiac Resynchronization Therapy

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: UMC Utrecht · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-02-08
• Primary completion: 2023-10-01
• Completion: 2025-10-01
• First posted: 2021-09-22
• Last updated: 2025-04-01

Locations

7 sites across 1 country: Netherlands