Clinical trial NCT01640769: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Systolic Heart Failure
Keywords: Cardiomyopathy
Cardiac Resynchronization Therapy
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2012-07-16
Enrollment: 328
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Determination of response to image guided placement of cardiac ventricular pacing leads in cardiac resynchronization therapy (CRT)
timeFrame: 6 months
Secondary outcomes:
measure: To determine if image guided lead delivery will result in a higher rate of lead delivery to optimal myocardial segments.
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: London Health Sciences Centre
name: James White, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.