Imaging Study of Allocation of Pacing Targets in Cardiac Resynchronization Therapy

NCT01640769 | Completed DMC

• 1 other identifier: MAPIT-CRT
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

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

Keywords

Cardiomyopathy; Cardiac Resynchronization Therapy; Image guided therapy; Digital twins; Cardiac Magnetic Resonance Imaging; MRI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• All-cause mortality

  12 months

• Heart failure hospital admissions

  12 months

• improvement in 6-minute hall walk ≥ 30 meters or ≥ 10%

  6 months

• Improvement in New York Heart Association (NYHA) functional class by ≥ 1

  6 months

• Improvement in Quality of Life (QOL) score by ≥ 10 points

  6 months

Study Arms (2)

Image guided delivery of pacing leads

ACTIVE COMPARATOR

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

Standard delivery of pacing leads

PLACEBO COMPARATOR

Standard LV and RV lead placement

Procedure: Standard CRT lead delivery

Interventions

4D Model guided delivery of cardiac pacing leads PROCEDURE

4D model-guided placement of LV and RV leads to optimal myocardial targets, as derived from pre-procedural Cardiac MRI

Image guided delivery of pacing leads

Standard CRT lead delivery PROCEDURE

Standard lead delivery

Standard delivery of pacing leads

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Libin Cardiovascular Institute of Alberta: lead
• Heart and Stroke Foundation of Canada: collaborator

Study Sites (5)

Conect Research, University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

Location

Halifax Capital Districy Health Authority

Halifax, Nova Scotia, B3H3A7, Canada

Location

Libin Cardiovascular Institute

London, Ontario, N6A5A5, Canada

Location

Ottawa Heart Institute Research Corporation

Ottawa, Ontario, K1Y4W7, Canada

Location

University of Laval Research Centre

Québec, Quebec, G1V 4G5, Canada

Location

Related Publications (2)

• Chew DS, Vandenberk B, Exner DV, Labib D, Flewitt J, Mikami Y, Rivest S, Chan D, Manlucu J, Leong-Sit P, Rinne C, Birnie DH, Nery P, Sumner G, Ayala-Paredes F, Philippon F, Yee R, White JA. 4D Digital Heart Model-Guided Left and Right Ventricular Lead Placement for Cardiac Resynchronization Therapy: Results of MAPIT-CRT Trial. Circ Arrhythm Electrophysiol. 2025 Dec 25:e014132. doi: 10.1161/CIRCEP.125.014132. Online ahead of print.

  PMID: 41446931 DERIVED

• 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.

  PMID: 25221334 DERIVED

MeSH Terms

Conditions

Heart Failure, Systolic; Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases

Study Officials

• James White, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 4 dimensional cardiac model to guide optimal delivery of left and right ventricular pacing leads in patients referred for cardiac resynchronization therapy.

Study Record Dates

• First Submitted: July 9, 2012
• First Posted: July 16, 2012
• Study Start: September 1, 2014
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2023
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5)