8
Participants
Start Date
March 8, 2018
Primary Completion Date
June 20, 2019
Study Completion Date
June 20, 2019
Conventional CRT
Patients randomized to the Conventional CRT will receive a CRT device with or without ICD. Device implantation will be performed within 10 working days of randomization. Conscious sedation or general anesthesia can be used for the implant procedure. The device will be implanted in a facility that has the capacity to perform coronary sinus venography at the time of implantation. The RA lead will be placed in the RA appendage or high RA. The RV lead should be placed at the RV apex or distal RV septum (R wave \> 7 mV, pacing threshold \< 1.5 V at a pulse-width of 0.5 ms). The LV lead should be positioned through the CS to an LV branch. The lead should be placed at one of the left ventricular venous branches, avoiding the LV apex and scar region identified by pre-implant imaging.
LV endocardial CRT
Patients randomized to LV endocardial CRT will receive a CRT device with or without ICD, placed in the same time frame, and will have RA and RV leads implanted as the conventional CRT group. The device will be implanted in a facility that has the capacity to perform trans-atrial septal puncture with ultrasound guidance (TEE or ICE) at the time of implantation. The LV lead will be placed using a trans-atrial septal approach, using a specially designed puncture tools and LVendo delivery tool kits specifically designed for this study. Special care will be taken to avoid the LV apex and transmural scar identified by pre-implant imaging.
Libin Cardiovascular Institute, Calgary
Royal Columbia Hospital, New Westminster
Queen Elizabeth II Health Science, Halifax
London Health Science Centre, London
University of Ottawa Heart Institute, Ottawa
St. Michael Hospital, Toronto
McGill University Health Centre, Montreal
Montreal Heart Institute, Montreal
Institut Univ.cardiologie/pneumologie de Québec, Québec
CHUS Le Centre hospitalier universitaire de Sherbrooke, Sherbrooke
Vancouver General Hospital, Vancouver
Collaborators (1)
Medtronic
INDUSTRY
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
OTHER