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Completed

NCT Number: NCT01640769

Imaging Study of 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.

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Key information

Conditions

Systolic Heart Failure Cardiac Resynchronization Therapy Cardiomyopathies Cardiovascular Diseases Digital Twins Dysynchrony Heart Diseases Heart Failure Heart Failure, Systolic Image Guidance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Conect Research, University of Calgary, Calgary, Alberta, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

Standard CRT lead delivery

Procedure

Standard lead delivery

Primary outcomes

  1. Determination of response to image guided placement of cardiac ventricular pacing leads in cardiac resynchronization therapy (CRT)

    Time frame: 6 months

    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).

Secondary outcomes

  1. All-cause mortality

    Time frame: 12 months

  2. Heart failure hospital admissions

    Time frame: 12 months

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

    Time frame: 6 months

    6 minute hallwalk will be done at baseline, 3 months and 6 months

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

    Time frame: 6 months

    NYHA class will be determined at baseline, 3 months and 6 months (score out of 4)

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

    Time frame: 6 months

    A "Minnesota Living with Heart Failure" questionnaire will be administered at baseline, 3 months and 6 months (visual analogue score out of 100)

  6. Rate of concordant lead delivery to the "optimal myocardial target"

    Time frame: 6 month

    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.

  7. Total procedural time

    Time frame: 6 month

    Total procedural time from first needle to skin closure, in minutes

  8. Fluoroscopy dose and exposure time

    Time frame: 6 month

    Total fluoroscopy exposure time and radiation dose will be recorded at end of procedure and recorded (in minutes).

  9. Procedural complications

    Time frame: 6 months

    All procedural complications will be recorded following completion of procedure and at 3 and 6 months.

  10. Device complications

    Time frame: 6 months

    All device-related complications, inclusive of need for lead repositioning, will be recorded at 3 months and 6 months.

Sponsors and collaborators

Lead sponsor

Libin Cardiovascular Institute of Alberta

Other

Collaborators

  • Heart and Stroke Foundation of Canada

Registry information

Official study title

MRI Allocation of Pacing Targets in Cardiac Resynchronization Therapy

Important dates

Study start
2014
Primary completion
2022
Study completion
2023
First posted
Jul 16, 2012
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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