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
About this trial
This is an interventional treatment trial for Systolic Heart Failure focused on measuring Cardiomyopathy, Cardiac Resynchronization Therapy
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.
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
NCT ID
NCT01640769
First Posted
July 9, 2012
Last Updated
July 11, 2012
Sponsor
Lawson Health Research Institute
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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