Resynchronization for Ambulatory Heart Failure Trial - LV Endocardial

NATerminatedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

March 8, 2018

Primary Completion Date

June 20, 2019

Study Completion Date

June 20, 2019

Conditions
Heart Failure, Left Ventricular Dysfunction
Interventions
DEVICE

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.

DEVICE

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.

Trial Locations (11)

Unknown

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

K4A 3B2

Vancouver General Hospital, Vancouver

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Medtronic

INDUSTRY

lead

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER