Resynchronization for Ambulatory Heart Failure Trial - LV Endocardial

Not Applicable

Terminated

• Conditions: Heart Failure, Left Ventricular Dysfunction

• Registration Number: NCT02757976
• Lead Sponsor: Lawson Health Research Institute

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 Timeline

• Study First Submitted: 2016-04-28
• Study First Submitted QC: 2016-04-28
• Study First Posted: 2016-05-02
• Study Start: 2018-03-08
• Primary Completion: 2019-06-20
• Study Completion: 2019-06-20
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-02
• Last Update Posted: 2020-09-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Assessment of LVESVi	Baseline to 6 months & 12 months	LV reverse remodeling as measured by the difference of LVESVi on echocardiography (echo)

Secondary Outcome Measures

Name	Time	Method
NT-proBNP measurement	Baseline to 6 months & 12 months
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
6 Minute Hall Walk Distance	Baseline to 6 months & 12 months
Quality of Life Measure	Baseline to 6 months & 12 months	EQ5D-5L \& Minnesota Living with HF
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

Trial Locations

Locations (11)

Libin Cardiovascular Institute; 🇨🇦 Calgary, Alberta, Canada

Royal Columbia Hospital; 🇨🇦 New Westminster, British Columbia, Canada

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Queen Elizabeth II Health Science; 🇨🇦 Halifax, Nova Scotia, Canada

London Health Science Centre; 🇨🇦 London, Ontario, Canada

University of Ottawa Heart Institute; 🇨🇦 Ottawa, Ontario, Canada

St. Michael Hospital; 🇨🇦 Toronto, Ontario, Canada

McGill University Health Centre; 🇨🇦 Montréal, Quebec, Canada

Montreal Heart Institute; 🇨🇦 Montréal, Quebec, Canada

Institut Univ.cardiologie/pneumologie de Québec; 🇨🇦 Quebec City, Quebec, Canada

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