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Imaging Study of Allocation of Pacing Targets in Cardiac Resynchronization Therapy

This study is not yet open for participant recruitment.
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Verified July 2012 by James White, Lawson Health Research Institute
Sponsor:
Information provided by (Responsible Party):
James White, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01640769
First received: July 9, 2012
Last updated: July 11, 2012
Last verified: July 2012
  Purpose
Magnetic Resonance Image guided delivery of Left and Right Ventricular Leads to optimal myocardial targets will result in improved clinical response to CRT using Left Ventricular remodeling criteria.

Condition Intervention Phase
Systolic Heart Failure Procedure: Image guided delivery of cardiac pacing leads. Procedure: Standard delivery of cardiac pacing leads. Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: MRI Allocation of Pacing Targets in Cardiac Resynchronization Therapy

Further study details as provided by James White, Lawson Health Research Institute:

Primary Outcome Measures:
  • 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 ( cardiac wall motion study) scan.


Secondary Outcome Measures:
  • To determine if image guided lead delivery will result in a higher rate of lead delivery to optimal myocardial segments. [ Time Frame: 3 months ]
    Cardiac CT scan will be performed at 3 months post CRT device implantation to determine secondary outcome listed above. The left ventricular (LV) lead site will be assessed for targets of dysychronous myocardium and proximity to scar tissue. The right ventricular (RV) lead will be assessed for proximity to scar tissue.


Estimated Enrollment: 328
Study Start Date: August 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Image guided delivery of pacing leads
Patients will be blindly randomized to image guided delivery of pacing leads during cardiac resynchronization therapy device implantation (study arm) versus standard implantation of pacing leads during cardiac resynchronization therapy device implantation (control arm).
Procedure: Image guided delivery of cardiac pacing leads.
Patients will be blindly randomized to image guided delivery of pacing leads during cardiac resynchronization therapy device implantation (study arm).
Placebo Comparator: Standard delivery of pacing leads
Patients will be blindly randomized to standard implantation of pacing leads during cardiac resynchronization therapy device implantation (control arm).
Procedure: Standard delivery of cardiac pacing leads.
Patients will be blindly randomized to standard implantation of pacing leads during cardiac resynchronization therapy device implantation (control arm).

Detailed Description:

Cardiac Dyssynchrony and scar are important variables for realization of clinical response to cardiac resynchronization therapy (CRT). Results from a previous study suggest that paced heart segment characteristics do predict this response and our ability to identify venous pathways to optimal segments is feasible using cardiac CT and MRI. In an ongoing feasibility study we are using these capabilities to guide the delivery of CRT lead systems to optimal myocardial targets. A computer software program has been developed that can create an interactive, 3D integrated cardiac model of coronary vein anatomy, myocardial scar and mechanical dyssynchrony. Although this feasibility study is ongoing, early results show this method of guiding the CRT leads to optimal targets with these individualized models to be safe and effective.

This trial will be a larger multi-centre randomized blinded trial to determine the therapeutic impact of MRI guided Left Ventricular and Right Ventricular lead placement with respect to improving clinical response rates for CRT.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years.
  2. Ejection fraction ≤ 35 %.
  3. 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. Standard contra-indications to MRI.
  5. Documented severe allergy to intravenous contrast dye ( iodinated CT contrast or Gadolinium MRI contrast).
  6. Estimated Glomerular Filtration Rate (eGFR) ≤ 45 ml/min/m2.
  7. Patient is pregnant.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01640769

Contacts
Contact: Kristine Carter, RN 519-685-8300 ext 24272 kris.carter@lhsc.on.ca

Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: James White, MD London Health Sciences Centre
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: James White, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01640769     History of Changes
Other Study ID Numbers: MAPIT-CRT
Study First Received: July 9, 2012
Last Updated: July 11, 2012

Keywords provided by James White, Lawson Health Research Institute:
Cardiomyopathy
Cardiac Resynchronization Therapy

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 22, 2017