This randomized controlled trial will assess a cardiac MRI derived 4D digital cardiac model to optimized left and right ventricular lead delivery to improve response to cardiac resynchronization therapy.
Regional mechanical delay, myocardial scar, and inter-lead distance have each been demonstrated to be relevant variables for the realization of optimal response to cardiac resynchronization therapy (CRT). Pilot study results have suggested clinical feasibility and potential value from LV and RV lead navigation aimed at optimizing these combined variables. A computer software program has been developed to deliver an interactive, 4D digital heart model of mechanical dyssynchrony and myocardial scar to guide LV and RV CRT lead delivery to optimal targets. This multi-center randomized clinical trial has been designed to assess the feasibility, safety and clinical impact of LV-RV lead navigation using a web-deployed 4D cardiac model.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
210
4D model-guided placement of LV and RV leads to optimal myocardial targets, as derived from pre-procedural Cardiac MRI
Standard lead delivery
Conect Research, University of Calgary
Calgary, Alberta, Canada
Halifax Capital Districy Health Authority
Halifax, Nova Scotia, Canada
Libin Cardiovascular Institute
London, Ontario, Canada
Ottawa Heart Institute Research Corporation
Ottawa, Ontario, Canada
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 (multigated acquisition scan / wall motion study).
Time frame: 6 months
All-cause mortality
Time frame: 12 months
Heart failure hospital admissions
Time frame: 12 months
improvement in 6-minute hall walk ≥ 30 meters or ≥ 10%
6 minute hallwalk will be done at baseline, 3 months and 6 months
Time frame: 6 months
Improvement in New York Heart Association (NYHA) functional class by ≥ 1
NYHA class will be determined at baseline, 3 months and 6 months (score out of 4)
Time frame: 6 months
Improvement in Quality of Life (QOL) score by ≥ 10 points
A "Minnesota Living with Heart Failure" questionnaire will be administered at baseline, 3 months and 6 months (visual analogue score out of 100)
Time frame: 6 months
Rate of concordant lead delivery to the "optimal myocardial target"
On the day of procedure, a post lead implant bi-plane fluoroscopy image and PA-LAT CXR will be obtained. These will be reviewed by a core laboratory to score final lead tip (electrode) location using a standardized report form to determine delivery location based on the AHA segmental model.
Time frame: 6 month
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Laval Research Centre
Québec, Quebec, Canada
Total procedural time
Total procedural time from first needle to skin closure, in minutes
Time frame: 6 month
Fluoroscopy dose and exposure time
Total fluoroscopy exposure time and radiation dose will be recorded at end of procedure and recorded (in minutes).
Time frame: 6 month
Procedural complications
All procedural complications will be recorded following completion of procedure and at 3 and 6 months.
Time frame: 6 months
Device complications
All device-related complications, inclusive of need for lead repositioning, will be recorded at 3 months and 6 months.
Time frame: 6 months