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Imaging Study of Allocation of Pacing Targets in Cardiac Resynchronization Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01640769
Recruitment Status : Unknown
Verified July 2012 by James White, Lawson Health Research Institute.
Recruitment status was:  Not yet recruiting
First Posted : July 16, 2012
Last Update Posted : July 16, 2012
Sponsor:
Information provided by (Responsible Party):
James White, Lawson Health Research Institute

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Systolic Heart Failure Procedure: Image guided delivery of cardiac pacing leads. Procedure: Standard delivery of cardiac pacing leads. Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 328 participants
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
Study Start Date : August 2012
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017
Arms and Interventions
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Arm Intervention/treatment
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).


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


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01640769


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

Sponsors and Collaborators
Lawson Health Research Institute
Investigators
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Principal Investigator: James White, MD London Health Sciences Centre
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: James White, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01640769    
Other Study ID Numbers: MAPIT-CRT
First Posted: July 16, 2012    Key Record Dates
Last Update Posted: July 16, 2012
Last Verified: July 2012
Keywords provided by James White, Lawson Health Research Institute:
Cardiomyopathy
Cardiac Resynchronization Therapy
Additional relevant MeSH terms:
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Heart Failure, Systolic
Heart Failure
Heart Diseases
Cardiovascular Diseases