This trial will compare two strategies for patients with Heart Failure, Left Ventricular systolic dysfunction, and intermediate QRS durations. The control group is conventional CRT. The experimental group is LVendo 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. 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. 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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
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.
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, Alberta, Canada
Royal Columbia Hospital
New Westminster, British Columbia, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
Assessment of LVESVi
LV reverse remodeling as measured by the difference of LVESVi on echocardiography (echo)
Time frame: Baseline to 6 months & 12 months
Ventricular arrhythmia burden determined by the device capture of arrhythmias and adjudication by a device review committee blinded to patient's treatment allocation.
Time frame: Baseline to 6 months & 12 months
NT-proBNP measurement
Time frame: Baseline to 6 months & 12 months
6 Minute Hall Walk Distance
Time frame: Baseline to 6 months & 12 months
Quality of Life Measure
EQ5D-5L \& Minnesota Living with HF
Time frame: Baseline to 6 months & 12 months
Mortality
Time frame: Baseline to 6 months & 12 months
Heart Failure Admissions
Time frame: Baseline to 6 months & 12 months
Reduction of LVEF
Time frame: Baseline to 6 months & 12 months
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Queen Elizabeth II Health Science
Halifax, Nova Scotia, Canada
London Health Science Centre
London, Ontario, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
St. Michael Hospital
Toronto, Ontario, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Institut Univ.cardiologie/pneumologie de Québec
Québec, Quebec, Canada
...and 1 more locations