Heart Failure, Left Ventricular DysfunctionRAFT-LVendoNCT02757976
Resynchronization for Ambulatory Heart Failure Trial - LV Endocardial
A study testing Conventional CRT and LV endocardial CRT in people with Heart Failure, Left Ventricular Dysfunction, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 11 sites in Canada.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Left Ventricular Dysfunction
- What is being tested?
- Conventional CRT and LV endocardial CRT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 11 sitesCanada
- Study dates
- 8 Mar 2018to 20 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Canada11 sites
Libin Cardiovascular Institute
Calgary, Alberta
Queen Elizabeth II Health Science
Halifax, Nova Scotia
London Health Science Centre
London, Ontario
McGill University Health Centre
Montreal, Quebec
Montreal Heart Institute
Montreal, Quebec
Royal Columbia Hospital
New Westminster, British Columbia
University of Ottawa Heart Institute
Ottawa, Ontario
Institut Univ.cardiologie/pneumologie de Québec
Québec, Quebec
CHUS Le Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec
St. Michael Hospital
Toronto, Ontario
Vancouver General Hospital
Vancouver, British Columbia, K4A 3B2
About this study
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
Read the 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
- Being tested
- Conventional CRT, LV endocardial CRT
- Medical subject headings
- Heart Failure, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional CRTDevice
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.
LV endocardial CRTDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional CRT | Active comparator | 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 Receives: Device: Conventional CRT |
| LV endocardial CRT | Experimental | 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. Receives: Device: LV endocardial CRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of LVESVi
LV reverse remodeling as measured by the difference of LVESVi on echocardiography (echo)
Measured: Baseline to 6 months & 12 months
Secondary outcomes (7)
Ventricular arrhythmia burden determined by the device capture of arrhythmias and adjudication by a device review committee blinded to patient's treatment allocation.
Measured: Baseline to 6 months & 12 months
NT-proBNP measurement
Measured: Baseline to 6 months & 12 months
6 Minute Hall Walk Distance
Measured: Baseline to 6 months & 12 months
Quality of Life Measure
EQ5D-5L \& Minnesota Living with HF
Measured: Baseline to 6 months & 12 months
Mortality
Measured: Baseline to 6 months & 12 months
Heart Failure Admissions
Measured: Baseline to 6 months & 12 months
Reduction of LVEF
Measured: Baseline to 6 months & 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study start8 Mar 2018
- Primary completion20 Jun 2019
- Study completion20 Jun 2019
Why it stopped: Consensus RAFT-LVendo Steering Committee to terminate.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, Left Ventricular DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02757976
- Sponsor's protocol ID
- 252410
- Acronym
- RAFT-LVendo
- Status last verified
- Sep 2020
- First submitted
- 28 Apr 2016
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resynchronization for Ambulatory Heart Failure Trial - LV Endocardial
- ClinicalTrials.gov ID
- NCT02757976
- Acronym / sponsor ID
- RAFT-LVendo / 252410
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Consensus RAFT-LVendo Steering Committee to terminate.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 8 Mar 2018 (actual)
- Primary completion
- 20 Jun 2019 (actual)
- Study completion
- 20 Jun 2019 (actual)
- First posted
- 2 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Conventional CRT | Active comparator | Device: Conventional CRTPatients 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 |
| LV endocardial CRT | Experimental | Device: LV endocardial CRTPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional CRTPatients 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 |
| LV endocardial CRTPatients 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 |
Primary outcome
Assessment of LVESVi
Time frame: Baseline to 6 months & 12 months
LV reverse remodeling as measured by the difference of LVESVi on echocardiography (echo)
7 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.
Time frame: Baseline to 6 months & 12 months
NT-proBNP measurement
Time frame: Baseline to 6 months & 12 months
6 Minute Hall Walk Distance
Time frame: Baseline to 6 months & 12 months
Quality of Life Measure
Time frame: Baseline to 6 months & 12 months
Mortality
Time frame: Baseline to 6 months & 12 months
Heart Failure Admissions
Time frame: Baseline to 6 months & 12 months
Reduction of LVEF
Time frame: Baseline to 6 months & 12 months
Results and safety
The study was stopped early (reason given: Consensus RAFT-LVendo Steering Committee to terminate.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional CRT and LV endocardial CRT in people with Heart Failure, Left Ventricular Dysfunction, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 11 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Consensus RAFT-LVendo Steering Committee to terminate.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of LVESVi (time frame: Baseline to 6 months & 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2020; AzTrials last refreshed its copy on 1 Nov 2026.