Resynchronization for Ambulatory Heart Failure Trial - LV Endocardial - Clinical Trial for Heart Failure, Left Ventricular Dysfunction | NCT02757976

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Primary Purpose

Status

Terminated

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Conventional CRT

LV endocardial CRT

About this trial

This is an interventional treatment trial for Heart Failure, Left Ventricular Dysfunction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional CRT

LV endocardial CRT

Arm 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. 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

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.

Outcomes

Primary Outcome Measures

Assessment of LVESVi

LV reverse remodeling as measured by the difference of LVESVi on echocardiography (echo)

Secondary Outcome Measures

Ventricular arrhythmia burden determined by the device capture of arrhythmias and adjudication by a device review committee blinded to patient's treatment allocation.

NT-proBNP measurement

6 Minute Hall Walk Distance

Quality of Life Measure

EQ5D-5L & Minnesota Living with HF

Mortality

Heart Failure Admissions

Reduction of LVEF

Full Information

NCT ID

NCT02757976

First Posted

April 28, 2016

Last Updated

September 2, 2020

Sponsor

Lawson Health Research Institute

Collaborators

Medtronic

1. Study Identification

Unique Protocol Identification Number

NCT02757976

Brief Title

Resynchronization for Ambulatory Heart Failure Trial - LV Endocardial

Acronym

RAFT-LVendo

Official Title

Resynchronization for Ambulatory Heart Failure Trial - LV Endocardial

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Terminated

Why Stopped

Consensus RAFT-LVendo Steering Committee to terminate.

Study Start Date

March 8, 2018 (Actual)

Primary Completion Date

June 20, 2019 (Actual)

Study Completion Date

June 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lawson Health Research Institute

Collaborators

Medtronic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure, Left Ventricular Dysfunction

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Conventional CRT

Arm Type

Active Comparator

Arm 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. 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

Arm Title

LV endocardial CRT

Arm Type

Experimental

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

Conventional CRT

Intervention 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. 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.

Intervention Type

Device

Intervention Name(s)

LV endocardial CRT

Intervention Description

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.

Primary Outcome Measure Information:

Title

Assessment of LVESVi

Description

LV reverse remodeling as measured by the difference of LVESVi on echocardiography (echo)

Time Frame