Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT03573427
Status:
WITHDRAWN
Last Update Posted:
2019-07-24
First Post:
2018-06-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
LV Endocardial CRT for Patients With Intermediate QRS Width
Sponsor:
Jaimie Manlucu
Organization:
Study Overview
Official Title:
LV Endocardial CRT for Patients With Intermediate QRS Width
Status:
WITHDRAWN
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No patients enrolled; Executive Committee Decision;Feasibility of recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EndoCRT
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: