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Imaging Study of Allocation of Pacing Targets in Cardiac Resynchronization Therapy

MRI Allocation of Pacing Targets in Cardiac Resynchronization Therapy

NCT01640769•Libin Cardiovascular Institute of Alberta

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥ 18 years.
•2. Ejection fraction ≤ 35 %.
•3. LBBB with QRS duration ≥ 120 msec.
•4. NYHA class II-IV.
•5. On maximum tolerated heart failure medication therapy ≥ 6 weeks.
•6. Clinically accepted for CRT device implantation.

Exclusion Criteria

•1. Failure to provide consent.
•2. CCS class III-IV angina.
•3. Recent Q-wave myocardial infarction or revascularization procedure ( ≤ 3 months).
•4. Atrial fibrillation at time of randomization \>6 weeks in duration
•5. Standard contra-indications to MRI.
•6. Documented severe allergy to intravenous contrast dye ( iodinated CT contrast or Gadolinium MRI contrast).
•7. Estimated Glomerular Filtration Rate (eGFR) ≤ 45 ml/min/m2.
•8. Patient is pregnant.

Locations (5)

Conect Research, University of Calgary

Calgary, Alberta, Canada

Halifax Capital Districy Health Authority

Halifax, Nova Scotia, Canada

Libin Cardiovascular Institute

London, Ontario, Canada

Ottawa Heart Institute Research Corporation

Ottawa, Ontario, Canada

University of Laval Research Centre

Québec, Quebec, Canada

Key Dates

Start Date

September 1, 2014

Primary Completion Date

January 1, 2022

Completion Date

January 1, 2023

Last Updated

June 25, 2025

Enrollment

210

ACTUAL participants

Conditions

Systolic Heart FailureDysynchronyImage GuidanceDigital TwinsCardiac Resynchronization Therapy

Interventions

4D Model guided delivery of cardiac pacing leads

PROCEDURE

Standard CRT lead delivery

PROCEDURE

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COMPLETED

Impact of Catheter Ablation of Ventricular Arrhythmias on Suboptimal Biventricular Pacing in Cardiac Resynchronization Therapy

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Imaging Study of Allocation of Pacing Targets in Cardiac Resynchronization Therapy

Inclusion Criteria

Exclusion Criteria

A Registry-based Cluster Randomized Trial to Compare the Effect of Spironolactone vs. Eplerenone on Clinical Outcomes in Patients With Symptomatic Systolic Heart Failure

Impact of Catheter Ablation of Ventricular Arrhythmias on Suboptimal Biventricular Pacing in Cardiac Resynchronization Therapy

A Pilot Trial of Patient Decision Aids for Implantable Cardioverter-Defibrillators (ICDs)

Renal Artery Denervation in Chronic Heart Failure Study

Effect of Nitrate-rich Beetroot Juice on Exercise Performance in Heart Failure Patients

Pilot Study Using Echocardiography to Evaluate Patients With Heart Failure and Dyssynchrony Who Have a CRT-D Device