NCT03573427

LV Endocardial CRT for Patients With Intermediate QRS Width

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Jaimie Manlucu · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Heart Failure，Congestive
• Left Ventricular Dysfunction
• Left Bundle-Branch Block

Interventions

Type	Name	Description
DEVICE	Trans-atrial septal placement LV lead for CRT

Timeline

• Start date: 2016-04-28
• Primary completion: 2019-04-28
• Completion: 2019-07-22
• First posted: 2018-06-29
• Last updated: 2019-07-24

Locations

8 sites across 1 country: Canada