Resynchronization for Ambulatory Heart Failure Trial - LV Endocardial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 8
- Locations
- 12
- Primary Endpoint
- Assessment of LVESVi
Study Overview
Brief Summary
This trial will compare two strategies for patients with Heart Failure, Left Ventricular systolic dysfunction, and intermediate QRS durations. The control group is conventional CRT. The experimental group is LVendo CRT
Detailed Description
Patients randomized to the Conventional CRT will receive a CRT device with or without ICD. Device implantation will be performed within 10 working days of randomization.
Patients randomized to LV endocardial CRT 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 conventional CRT group. The device will be implanted in a facility that has the capacity to perform trans-atrial septal puncture with ultrasound guidance. The LV lead will be placed using a trans-atrial septal approach using a specially designed puncture tools and LVendo delivery tool kits specifically designed for this study
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with NYHA Class II or III or ambulatory IV 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 durations more than or equal to 120 ms, but less than 150 ms
- •Patients are able to receive chronic oral anticoagulation
- •Patients with pacemaker or ICD that meet the above criteria may be upgraded to CRT-D or CRT-P
Exclusion Criteria
- •Planned Atrial Fibrillation Ablation within 12 months
- •Patients with mitral or tricuspid prosthetic valve that precludes the placement of an LV lead transvenously or trans-septally
- •Patients with RBBB
- •Patients with LV thrombus
- •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
- •Expected to undergo cardiac transplantation within one year (status I)
- •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
Outcomes
Primary Outcomes
Assessment of LVESVi
Time Frame: Baseline to 6 months & 12 months
LV reverse remodeling as measured by the difference of LVESVi on echocardiography (echo)
Secondary Outcomes
- Ventricular arrhythmia burden determined by the device capture of arrhythmias and adjudication by a device review committee blinded to patient's treatment allocation.(Baseline to 6 months & 12 months)
- NT-proBNP measurement(Baseline to 6 months & 12 months)
- 6 Minute Hall Walk Distance(Baseline to 6 months & 12 months)
- Quality of Life Measure(Baseline to 6 months & 12 months)
- Mortality(Baseline to 6 months & 12 months)
- Heart Failure Admissions(Baseline to 6 months & 12 months)
- Reduction of LVEF(Baseline to 6 months & 12 months)