Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT03573427
Brief 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.
Study:
NCT03573427
Study Brief:
Protocol Section:
NCT03573427