Imaging Study of Allocation of Pacing Targets in Cardiac Resynchronization Therapy

MRI Allocation of Pacing Targets in Cardiac Resynchronization Therapy

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.

Study Overview

• Status: Completed
• Conditions: Image Guidance; Cardiac Resynchronization Therapy; Systolic Heart Failure; Dysynchrony; Digital Twins
• Intervention / Treatment: Procedure: 4D Model guided delivery of cardiac pacing leads; Procedure: Standard CRT lead delivery

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.

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • Conect Research, University of Calgary
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H3A7
      • Halifax Capital Districy Health Authority
  • Ontario
    • London, Ontario, Canada, N6A5A5
      • Libin Cardiovascular Institute
    • Ottawa, Ontario, Canada, K1Y4W7
      • Ottawa Heart Institute Research Corporation
  • Quebec
    • Quebec City, Quebec, Canada, G1V 4G5
      • University of Laval Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Image guided delivery of pacing leads; 4D model-guided placement of LV and RV leads to optimal myocardial targets, as derived from pre-procedural Cardiac MRI	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
Placebo Comparator: Standard delivery of pacing leads; Standard LV and RV lead placement	Procedure: Standard CRT lead delivery; Standard lead delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of response to image guided placement of cardiac ventricular pacing leads in cardiac resynchronization therapy (CRT)	Cardiac Resynchronization Therapy (CRT) response will be defined as a change in the Left Ventricular Ejection Fraction measured at 6 months post CRT device implant by MUGA (multigated acquisition scan / wall motion study).	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality		12 months
Heart failure hospital admissions		12 months
improvement in 6-minute hall walk ≥ 30 meters or ≥ 10%	6 minute hallwalk will be done at baseline, 3 months and 6 months	6 months
Improvement in New York Heart Association (NYHA) functional class by ≥ 1	NYHA class will be determined at baseline, 3 months and 6 months (score out of 4)	6 months
Improvement in Quality of Life (QOL) score by ≥ 10 points	A "Minnesota Living with Heart Failure" questionnaire will be administered at baseline, 3 months and 6 months (visual analogue score out of 100)	6 months
Rate of concordant lead delivery to the "optimal myocardial target"	On the day of procedure, a post lead implant bi-plane fluoroscopy image and PA-LAT CXR will be obtained. These will be reviewed by a core laboratory to score final lead tip (electrode) location using a standardized report form to determine delivery location based on the AHA segmental model.	6 month
Total procedural time	Total procedural time from first needle to skin closure, in minutes	6 month
Fluoroscopy dose and exposure time	Total fluoroscopy exposure time and radiation dose will be recorded at end of procedure and recorded (in minutes).	6 month
Procedural complications	All procedural complications will be recorded following completion of procedure and at 3 and 6 months.	6 months
Device complications	All device-related complications, inclusive of need for lead repositioning, will be recorded at 3 months and 6 months.	6 months

Collaborators and Investigators

• Sponsor: Libin Cardiovascular Institute of Alberta
• Collaborators: Heart and Stroke Foundation of Canada
• Investigators: Principal Investigator: James White, MD, University of Calgary

Publications and helpful links

General Publications

• Laksman Z, Yee R, Stirrat J, Gula LJ, Skanes AC, Leong-Sit P, Manlucu J, McCarty D, Turkistani Y, Scholl D, Rajchl M, Goela A, Islam A, Thompson RT, Drangova M, White JA. Model-based navigation of left and right ventricular leads to optimal targets for cardiac resynchronization therapy: a single-center feasibility study. Circ Arrhythm Electrophysiol. 2014 Dec;7(6):1040-7. doi: 10.1161/CIRCEP.114.001729. Epub 2014 Sep 14.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: July 9, 2012
• First Submitted That Met QC Criteria: July 11, 2012
• First Posted (Estimated): July 16, 2012

Study Record Updates

• Last Update Posted (Estimated): June 25, 2025
• Last Update Submitted That Met QC Criteria: June 18, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: MRI; Cardiomyopathy; Cardiac Resynchronization Therapy; Cardiac Magnetic Resonance Imaging; Image guided therapy; Digital twins
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure; Heart Failure, Systolic
• Other Study ID Numbers: MAPIT-CRT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No