LV Endocardial CRT for Patients With Intermediate QRS Width

Left Ventricular Dysfunction Clinical Trial

— EndoCRT  

Official title:

LV Endocardial CRT for Patients With Intermediate QRS Width

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03573427
• Other study ID #: V27Mar17
• Status: Withdrawn
• Start date: April 28, 2016
• Est. completion date: July 22, 2019

Study information

• Verified date: July 2019
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 22, 2019
• Est. primary completion date: April 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with NYHA Class II-IV ambulatory HF symptoms

• Optimal HF Medical Therapy of at least 3 months (2009 ACCF/AHA, ESC 2012)

• LVEF less than or equal to 35%

• Sinus rhythm (can have paroxysmal atrial fibrillation)

• QRS morphology is non-RBBB

• QRS duration 120-149 ms

• Patients with pacemaker or ICD that meet the above criteria may be upgraded to CRT-D or CRT-P

• Patients are able to receive oral anticoagulation

Exclusion Criteria:

• Patients with atrial septal defect closure

• Planned atrial fibrillation ablation within 12 months

• Patients with mitral prosthetic valve that precludes the placement of an LV lead trans-septally

• Patients with RBBB

• Patients with intra-cardiac thrombi

• Patients with permanent atrial fibrillation

• Patients with contraindications to oral anti-coagulation

• In-hospital patients with acute cardiac or non-cardiac illness that requires intensive care

• Acute coronary syndrome (including MI) < 4 weeks

• Coronary revascularization (CABG or PCI) < 3 months

• Uncorrected or uncorrectable primary valvular disease

• Restrictive, hypertrophic or reversible form of cardiomyopathy

• Severe primary pulmonary disease such as cor pulmonale

• Patients with a life expectancy of less than one year from non-cardiac cause.

• Patients included in other clinical trials that will affect the objectives of this study

• Those unable or unwilling to provide informed consent

• Those with a history of noncompliance to medical therapy

Related Conditions & MeSH terms

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

Intervention

Device:
• Trans-atrial septal placement LV lead for CRT

Locations

Country	Name	City	State
Canada	Queen Elizabeth II Health Science	Halifax	Nova Scotia
Canada	London Health Science Centre	London	Ontario
Canada	Centre hospitalier de l'Université de Montréal	Montréal	Quebec
Canada	McGill University Health Centre	Montréal	Quebec
Canada	Montreal Heart Institute	Montréal	Quebec
Canada	Sherbrooke CHUS	Sherbrooke	Quebec
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Jaimie Manlucu

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LV end-systolic volume	Echocardiogram	Change from Baseline measure to 6 months
Primary	LVEF improvement	Echocardiogram	Change from Baseline measure to 6 months
Secondary	Thromboembolic Events	Adverse Event	Through study completion, an average of 1 year
Secondary	Specific system placement procedure related adverse events	Device Implant	Through study completion, an average of 1 year
Secondary	Lead(s) dislodgement requiring repositioning or cessation of CRT	Chest xray, device interrogation	Through study completion, an average of 1 year
Secondary	Cardiac tamponade requiring intervention	Device Implant	Through study completion, an average of 1 year
Secondary	Ventricular Arrhythmias	Device interrogation	6 months, 12 months
Secondary	Mitral Regurgitation	Echocardiogram	Baseline, 6 months