NCT01640769

Imaging Study of Allocation of Pacing Targets in Cardiac Resynchronization Therapy

MRI Allocation of Pacing Targets in Cardiac Resynchronization Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: Libin Cardiovascular Institute of Alberta · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized controlled trial will assess a cardiac MRI derived 4D digital cardiac model to optimized left and right ventricular lead delivery to improve response to cardiac resynchronization therapy.

Detailed description

Regional mechanical delay, myocardial scar, and inter-lead distance have each been demonstrated to be relevant variables for the realization of optimal response to cardiac resynchronization therapy (CRT). Pilot study results have suggested clinical feasibility and potential value from LV and RV lead navigation aimed at optimizing these combined variables. A computer software program has been developed to deliver an interactive, 4D digital heart model of mechanical dyssynchrony and myocardial scar to guide LV and RV CRT lead delivery to optimal targets. This multi-center randomized clinical trial has been designed to assess the feasibility, safety and clinical impact of LV-RV lead navigation using a web-deployed 4D cardiac model.

Conditions

• Systolic Heart Failure
• Dysynchrony
• Image Guidance
• Digital Twins
• Cardiac Resynchronization Therapy

Interventions

Type	Name	Description
PROCEDURE	4D Model guided delivery of cardiac pacing leads	4D model-guided placement of LV and RV leads to optimal myocardial targets, as derived from pre-procedural Cardiac MRI
PROCEDURE	Standard CRT lead delivery	Standard lead delivery

Timeline

• Start date: 2014-09-01
• Primary completion: 2022-01-01
• Completion: 2023-01-01
• First posted: 2012-07-16
• Last updated: 2025-06-25

Locations

5 sites across 1 country: Canada