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Imaging Study of Allocation of Pacing Targets in Cardiac Resynchronization Therapy

Primary Purpose

Systolic Heart Failure

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Image guided delivery of cardiac pacing leads.
Standard delivery of cardiac pacing leads.
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systolic Heart Failure focused on measuring Cardiomyopathy, Cardiac Resynchronization Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Image guided delivery of pacing leads

    Standard delivery of pacing leads

    Arm Description

    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).

    Patients will be blindly randomized to standard implantation of pacing leads during cardiac resynchronization therapy device implantation (control arm).

    Outcomes

    Primary Outcome Measures

    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 ( 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.
    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.

    Full Information

    First Posted
    July 9, 2012
    Last Updated
    July 11, 2012
    Sponsor
    Lawson Health Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01640769
    Brief Title
    Imaging Study of Allocation of Pacing Targets in Cardiac Resynchronization Therapy
    Official Title
    MRI Allocation of Pacing Targets in Cardiac Resynchronization Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2012
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2012 (undefined)
    Primary Completion Date
    December 2016 (Anticipated)
    Study Completion Date
    December 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Lawson Health Research Institute

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Systolic Heart Failure
    Keywords
    Cardiomyopathy, Cardiac Resynchronization Therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    328 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Image guided delivery of pacing leads
    Arm Type
    Active Comparator
    Arm Description
    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).
    Arm Title
    Standard delivery of pacing leads
    Arm Type
    Placebo Comparator
    Arm Description
    Patients will be blindly randomized to standard implantation of pacing leads during cardiac resynchronization therapy device implantation (control arm).
    Intervention Type
    Procedure
    Intervention Name(s)
    Image guided delivery of cardiac pacing leads.
    Intervention Description
    Patients will be blindly randomized to image guided delivery of pacing leads during cardiac resynchronization therapy device implantation (study arm).
    Intervention Type
    Procedure
    Intervention Name(s)
    Standard delivery of cardiac pacing leads.
    Intervention Description
    Patients will be blindly randomized to standard implantation of pacing leads during cardiac resynchronization therapy device implantation (control arm).
    Primary Outcome Measure Information:
    Title
    Determination of response to image guided placement of cardiac ventricular pacing leads in cardiac resynchronization therapy (CRT)
    Description
    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.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    To determine if image guided lead delivery will result in a higher rate of lead delivery to optimal myocardial segments.
    Description
    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.
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age ≥ 18 years. Ejection fraction ≤ 35 %. 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). 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kristine Carter, RN
    Phone
    519-685-8300
    Ext
    24272
    Email
    kris.carter@lhsc.on.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    James White, MD
    Organizational Affiliation
    London Health Sciences Centre
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25221334
    Citation
    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.
    Results Reference
    derived

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    Imaging Study of Allocation of Pacing Targets in Cardiac Resynchronization Therapy

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