LV Endocardial CRT for Patients With Intermediate QRS Width

Study Overview
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Brief Summary
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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
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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.

Official Title
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LV Endocardial CRT for Patients With Intermediate QRS Width

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

Intervention / Treatment
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* Device: Trans-atrial septal placement LV lead for CRT


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Trans-atrial septal placement LV lead for CRT|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LV end-systolic volume | Echocardiogram | Change from Baseline measure to 6 months | 
| LVEF improvement | Echocardiogram | Change from Baseline measure to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thromboembolic Events | Adverse Event | Through study completion, an average of 1 year | 
| Specific system placement procedure related adverse events | Device Implant | Through study completion, an average of 1 year | 
| Lead(s) dislodgement requiring repositioning or cessation of CRT | Chest xray, device interrogation | Through study completion, an average of 1 year | 
| Cardiac tamponade requiring intervention | Device Implant | Through study completion, an average of 1 year | 
| Ventricular Arrhythmias | Device interrogation | 6 months, 12 months | 
| Mitral Regurgitation | Echocardiogram | Baseline, 6 months |