Clinical trial NCT03573427: LV Endocardial CRT for Patients With Intermediate QRS Width
Official title: LV Endocardial CRT for Patients With Intermediate QRS Width
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Heart Failure，Congestive
Left Ventricular Dysfunction
Left Bundle-Branch Block
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2018-06-29
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with left bundle branch block (LBBB) and a QRS width of 120-149 ms; ambulatory NYHA class II-IV heart failure symptoms; and a LV ejection fraction ≤ 35%

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.

Eligibility criteria: 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

Primary outcomes:
measure: LV end-systolic volume
timeFrame: Change from Baseline measure to 6 months
measure: LVEF improvement
timeFrame: Change from Baseline measure to 6 months
Secondary outcomes:
measure: Thromboembolic Events
timeFrame: Through study completion, an average of 1 year
measure: Specific system placement procedure related adverse events
timeFrame: Through study completion, an average of 1 year
measure: Lead(s) dislodgement requiring repositioning or cessation of CRT
timeFrame: Through study completion, an average of 1 year
measure: Cardiac tamponade requiring intervention
timeFrame: Through study completion, an average of 1 year
measure: Ventricular Arrhythmias
timeFrame: 6 months, 12 months
measure: Mitral Regurgitation
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Science
state: Nova Scotia
city: London
country: Canada
facility: London Health Science Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Montréal
country: Canada
facility: Centre hospitalier de l'Université de Montréal
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Montréal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Sherbrooke
country: Canada
facility: Sherbrooke CHUS
state: Quebec
Study officials:
affiliation: Schulich School of Medicine, Western University, London Health Sciences Centre
name: Jaimie Manlucu, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References: