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.
Study Type
OBSERVATIONAL
Vancouver General Hospital
Vancouver, British Columbia, Canada
Queen Elizabeth II Health Science
Halifax, Nova Scotia, Canada
London Health Science Centre
London, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
LV end-systolic volume
Echocardiogram
Time frame: Change from Baseline measure to 6 months
LVEF improvement
Echocardiogram
Time frame: Change from Baseline measure to 6 months
Thromboembolic Events
Adverse Event
Time frame: Through study completion, an average of 1 year
Specific system placement procedure related adverse events
Device Implant
Time frame: Through study completion, an average of 1 year
Lead(s) dislodgement requiring repositioning or cessation of CRT
Chest xray, device interrogation
Time frame: Through study completion, an average of 1 year
Cardiac tamponade requiring intervention
Device Implant
Time frame: Through study completion, an average of 1 year
Ventricular Arrhythmias
Device interrogation
Time frame: 6 months, 12 months
Mitral Regurgitation
Echocardiogram
Time frame: Baseline, 6 months
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Centre hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Sherbrooke CHUS
Sherbrooke, Quebec, Canada