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Systolic Heart FailureNCT01640769

Imaging Study of Allocation of Pacing Targets in Cardiac Resynchronization Therapy

A study testing 4D Model guided delivery of cardiac pacing leads and Standard CRT lead delivery in people with Systolic Heart Failure and Dysynchrony, run by Libin Cardiovascular Institute of Alberta at 5 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
4D Model guided delivery of cardiac pacing leads and Standard CRT lead delivery
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
210 participants
Where
5 sitesCanada
Study dates
Sep 2014to Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Canada5 sites

  • Conect Research, University of Calgary

    Calgary, Alberta, T2N 4Z6

  • Halifax Capital Districy Health Authority

    Halifax, Nova Scotia, B3H3A7

  • Libin Cardiovascular Institute

    London, Ontario, N6A5A5

  • Ottawa Heart Institute Research Corporation

    Ottawa, Ontario, K1Y4W7

  • University of Laval Research Centre

    Québec, Quebec, G1V 4G5

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
4D Model guided delivery of cardiac pacing leads, Standard CRT lead delivery
Keywords
Cardiomyopathy, Cardiac Resynchronization Therapy, Image guided therapy, Digital twins, Cardiac Magnetic Resonance Imaging, MRI
Medical subject headings
Heart Failure, Systolic, Cardiomyopathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 4D Model guided delivery of cardiac pacing leadsProcedure or surgery

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

  • Standard CRT lead deliveryProcedure or surgery

    Standard lead delivery

Study groups in NCT01640769
Study groupRoleWhat they receive
Image guided delivery of pacing leadsActive comparator4D model-guided placement of LV and RV leads to optimal myocardial targets, as derived from pre-procedural Cardiac MRI
Receives: Procedure: 4D Model guided delivery of cardiac pacing leads
Standard delivery of pacing leadsPlacebo comparatorStandard LV and RV lead placement
Receives: Procedure: Standard CRT lead delivery

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 6 months

Secondary outcomes (10)

  1. All-cause mortality

    Measured: 12 months

  2. Heart failure hospital admissions

    Measured: 12 months

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

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

    Measured: 6 months

  4. 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)

    Measured: 6 months

  5. 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)

    Measured: 6 months

  6. 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.

    Measured: 6 month

  7. Total procedural time

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

    Measured: 6 month

  8. Fluoroscopy dose and exposure time

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

    Measured: 6 month

  9. Procedural complications

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

    Measured: 6 months

  10. Device complications

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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2012 (estimated)
  2. Study startSep 2014
  3. Primary completionJan 2022
  4. Study completionJan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
4 dimensional cardiac model to guide optimal delivery of left and right ventricular pacing leads in patients referred for cardiac resynchronization therapy.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
210 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01640769
Sponsor's protocol ID
MAPIT-CRT
Status last verified
Jun 2025
First submitted
9 Jul 2012
Last updated
25 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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 PB, 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. 2026 Jan;19(1):e014132. doi: 10.1161/CIRCEP.125.014132. Epub 2025 Dec 25.

    PubMed 41446931

  • 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.

    PubMed 25221334

Questions about this trial

What is this clinical trial studying?

A study testing 4D Model guided delivery of cardiac pacing leads and Standard CRT lead delivery in people with Systolic Heart Failure and Dysynchrony, run by Libin Cardiovascular Institute of Alberta at 5 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determination of response to image guided placement of cardiac ventricular pacing leads in cardiac resynchronization therapy (CRT) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01640769, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.

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