Clinical trial NCT02757976: Resynchronization for Ambulatory Heart Failure Trial - LV Endocardial
Official title: Resynchronization for Ambulatory Heart Failure Trial - LV Endocardial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure, Left Ventricular Dysfunction
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2016-05-02
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This trial will compare two management strategies for patients with Heart Failure, left ventricular systolic dysfunction, and intermediate prolonged QRS duration (120-149ms). The control group is conventional Cardiac Resynchronization Therapy (CRT). The experimental group is LV endocardial CRT.
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of LVESVi
timeFrame: Baseline to 6 months & 12 months
Secondary outcomes:
measure: Ventricular arrhythmia burden determined by the device capture of arrhythmias and adjudication by a device review committee blinded to patient's treatment allocation.
timeFrame: Baseline to 6 months & 12 months
measure: NT-proBNP measurement
timeFrame: Baseline to 6 months & 12 months
measure: 6 Minute Hall Walk Distance
timeFrame: Baseline to 6 months & 12 months
measure: Quality of Life Measure
timeFrame: Baseline to 6 months & 12 months
measure: Mortality
timeFrame: Baseline to 6 months & 12 months
measure: Heart Failure Admissions
timeFrame: Baseline to 6 months & 12 months
measure: Reduction of LVEF
timeFrame: Baseline to 6 months & 12 months
Other outcomes:
measure: Thromboembolic Events Investigator deemed to be directly related to the therapy
timeFrame: Baseline to 12 months
measure: Safety: LVendo CRT: specific system placement procedure related adverse events
timeFrame: Baseline to 12 months
measure: Safety:Pocket infection requiring extending hospitalization > 24 hours or requiring surgical intervention
timeFrame: Baseline to 12 months
measure: Safety:Lead(s) dislodgement requiring repositioning or cessation of CRT
timeFrame: Baseline to 12 months
measure: Safety:Cardiac tamponade requiring intervention
timeFrame: Baseline to 12 months
measure: Safety:Phrenic nerve stimulation
timeFrame: Baseline to 12 months
Locations:
city: Calgary
country: Canada
facility: Libin Cardiovascular Institute
state: Alberta
city: New Westminster
country: Canada
facility: Royal Columbia Hospital
state: British Columbia
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: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Toronto
country: Canada
facility: St. Michael Hospital
state: Ontario
city: Montréal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Montréal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Quebec City
country: Canada
facility: Institut Univ.cardiologie/pneumologie de Québec
state: Quebec
city: Sherbrooke
country: Canada
facility: CHUS Le Centre hospitalier universitaire de Sherbrooke
state: Quebec
Study officials:
References: