Imaging Study of Allocation of Pacing Targets in Cardiac Resynchronization Therapy

June 18, 2025 updated by: James White, Libin Cardiovascular Institute of Alberta

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
210

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: 12 months
12 months
Heart failure hospital admissions
Time Frame: 12 months
12 months
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
6 months
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)
6 months
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 months
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.
6 month
Total procedural time
Time Frame: 6 month
Total procedural time from first needle to skin closure, in minutes
6 month
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).
6 month
Procedural complications
Time Frame: 6 months
All procedural complications will be recorded following completion of procedure and at 3 and 6 months.
6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Libin Cardiovascular Institute of Alberta

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Heart and Stroke Foundation of Canada

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: James White, MD, University Of Calgary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2012

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2012

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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