Resynchronization for Ambulatory Heart Failure Trial - LV Endocardial (RAFT-LVendo)

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

Study Overview

• Status: Terminated
• Conditions: Heart Failure, Left Ventricular Dysfunction
• Intervention / Treatment: Device: Conventional CRT; Device: LV endocardial 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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • Libin Cardiovascular Institute
  • British Columbia
    • New Westminster, British Columbia, Canada
      • Royal Columbia Hospital
    • Vancouver, British Columbia, Canada, K4A 3B2
      • Vancouver General Hospital
  • Nova Scotia
    • Halifax, Nova Scotia, Canada
      • Queen Elizabeth II Health Science
  • Ontario
    • London, Ontario, Canada
      • London Health Science Centre
    • Ottawa, Ontario, Canada
      • University of Ottawa Heart Institute
    • Toronto, Ontario, Canada
      • St. Michael Hospital
  • Quebec
    • Montréal, Quebec, Canada
      • McGill University Health Centre
    • Montréal, Quebec, Canada
      • Montreal Heart Institute
    • Quebec City, Quebec, Canada
      • Institut Univ.cardiologie/pneumologie de Québec
    • Sherbrooke, Quebec, Canada
      • CHUS Le Centre hospitalier universitaire de Sherbrooke

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional CRT; 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. Conscious sedation or general anesthesia can be used for the implant procedure. The device will be implanted in a facility that has the capacity to perform coronary sinus venography at the time of implantation. The RA lead will be placed in the RA appendage or high RA. The RV lead should be placed at the RV apex or distal RV septum (R wave > 7 mV, pacing threshold < 1.5 V at a pulse-width of 0.5 ms). The LV lead should be positioned through the CS to an LV branch. The lead should be placed at one of the left ventricular venous branches, avoiding the LV apex and scar region identified by pre-implant imaging	Device: Conventional CRT; 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. Conscious sedation or general anesthesia can be used for the implant procedure. The device will be implanted in a facility that has the capacity to perform coronary sinus venography at the time of implantation. The RA lead will be placed in the RA appendage or high RA. The RV lead should be placed at the RV apex or distal RV septum (R wave > 7 mV, pacing threshold < 1.5 V at a pulse-width of 0.5 ms). The LV lead should be positioned through the CS to an LV branch. The lead should be placed at one of the left ventricular venous branches, avoiding the LV apex and scar region identified by pre-implant imaging.
Experimental: LV endocardial CRT; 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 (TEE or ICE) at the time of implantation. 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. Special care will be taken to avoid the LV apex and transmural scar identified by pre-implant imaging.	Device: LV endocardial CRT; 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 (TEE or ICE) at the time of implantation. 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. Special care will be taken to avoid the LV apex and transmural scar identified by pre-implant imaging.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of LVESVi	LV reverse remodeling as measured by the difference of LVESVi on echocardiography (echo)	Baseline to 6 months & 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	EQ5D-5L & Minnesota Living with HF	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thromboembolic Events Investigator deemed to be directly related to the therapy	Safety	Baseline to 12 months
Safety: LVendo CRT: specific system placement procedure related adverse events	Safety	Baseline to 12 months
Safety:Pocket infection requiring extending hospitalization > 24 hours or requiring surgical intervention		Baseline to 12 months
Safety:Lead(s) dislodgement requiring repositioning or cessation of CRT		Baseline to 12 months
Safety:Cardiac tamponade requiring intervention		Baseline to 12 months
Safety:Phrenic nerve stimulation		Baseline to 12 months

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Collaborators: Medtronic

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2018
• Primary Completion (Actual): June 20, 2019
• Study Completion (Actual): June 20, 2019

Study Registration Dates

• First Submitted: April 28, 2016
• First Submitted That Met QC Criteria: April 28, 2016
• First Posted (Estimate): May 2, 2016

Study Record Updates

• Last Update Posted (Actual): September 4, 2020
• Last Update Submitted That Met QC Criteria: September 2, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Ventricular Dysfunction; Ventricular Dysfunction, Left
• Other Study ID Numbers: 252410

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No