Left Ventricular Dysfunction Clinical Trial
Official title:
LV Endocardial CRT for Patients With Intermediate QRS Width
This pilot study is designed as a multi-centre cohort study determining the degree of LV reverse remodeling in patients with intermediate QRS widths (120-149ms) who undergo CRT implant with transseptal LV leads, and comparing to the average expected reverse remodeling rate in patients with standard transvenous coronary sinus leads and QRS widths ≥150ms.
This is a multi-centre prospective cohort trial to establish the feasibility of endocardial
CRT implants.This trial will assess feasibility of a larger scale randomized controlled
study.
Patients consented to the study 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 standard of care. 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 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. Electrical testing, and
programming of the device will be standardized.
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