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

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ClinicalTrials.gov Identifier: NCT02757976
Recruitment Status : Recruiting
First Posted : May 2, 2016
Last Update Posted : May 28, 2018
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Heart Failure, Left Ventricular Dysfunction Device: Conventional CRT Device: LV endocardial CRT Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Resynchronization for Ambulatory Heart Failure Trial - LV Endocardial
Actual Study Start Date : March 8, 2018
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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.




Primary Outcome Measures :
  1. Assessment of LVESVi [ Time Frame: Baseline to 6 months & 12 months ]
    LV reverse remodeling as measured by the difference of LVESVi on echocardiography (echo)


Secondary Outcome Measures :
  1. 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 ]
  2. NT-proBNP measurement [ Time Frame: Baseline to 6 months & 12 months ]
  3. 6 Minute Hall Walk Distance [ Time Frame: Baseline to 6 months & 12 months ]
  4. Quality of Life Measure [ Time Frame: Baseline to 6 months & 12 months ]
    EQ5D-5L & Minnesota Living with HF

  5. Mortality [ Time Frame: Baseline to 6 months & 12 months ]
  6. Heart Failure Admissions [ Time Frame: Baseline to 6 months & 12 months ]
  7. Reduction of LVEF [ Time Frame: Baseline to 6 months & 12 months ]

Other Outcome Measures:
  1. Thromboembolic Events Investigator deemed to be directly related to the therapy [ Time Frame: Baseline to 12 months ]
    Safety

  2. Safety: LVendo CRT: specific system placement procedure related adverse events [ Time Frame: Baseline to 12 months ]
    Safety

  3. Safety:Pocket infection requiring extending hospitalization > 24 hours or requiring surgical intervention [ Time Frame: Baseline to 12 months ]
  4. Safety:Lead(s) dislodgement requiring repositioning or cessation of CRT [ Time Frame: Baseline to 12 months ]
  5. Safety:Cardiac tamponade requiring intervention [ Time Frame: Baseline to 12 months ]
  6. Safety:Phrenic nerve stimulation [ Time Frame: Baseline to 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02757976


Contacts
Contact: Dr. Anthony Tang, MD FRCPC (519) 663-3746 anthonysltang@gmail.com
Contact: Dr. Jaimie Manlucu, MD FRCPC (519) 663-3746 jaimie.manlucu@lhsc.on.ca

Locations
Canada, Alberta
Libin Cardiovascular Institute Not yet recruiting
Calgary, Alberta, Canada
Contact: Derek Exner, MD         
Canada, British Columbia
Royal Columbia Hospital Not yet recruiting
New Westminster, British Columbia, Canada
Contact: Stanley Tung, MD         
Vancouver General Hospital Not yet recruiting
Vancouver, British Columbia, Canada, K4A 3B2
Contact: Matthew Bennett, MD         
Canada, Nova Scotia
Queen Elizabeth II Health Science Not yet recruiting
Halifax, Nova Scotia, Canada
Contact: Amir AbdelWahab, MD         
Canada, Ontario
London Health Science Centre Recruiting
London, Ontario, Canada
Contact: Dr. Jaimie Manlucu         
University of Ottawa Heart Institute Not yet recruiting
Ottawa, Ontario, Canada
Contact: Calum Redpath, MD         
St. Michael Hospital Not yet recruiting
Toronto, Ontario, Canada
Contact: Paul Angaran, MD         
Canada, Quebec
McGill University Health Centre Not yet recruiting
Montréal, Quebec, Canada
Contact: Vidal Essebag, M.D.         
Montreal Heart Institute Not yet recruiting
Montréal, Quebec, Canada
Contact: Bernard Thibault, M.D.         
Institut Univ.cardiologie/pneumologie de Québec Not yet recruiting
Quebec City, Quebec, Canada
Contact: Francois Philippon, MD         
CHUS Le Centre hospitalier universitaire de Sherbrooke Not yet recruiting
Sherbrooke, Quebec, Canada
Contact: Felix Ayala-Paredes, M.D.         
Sponsors and Collaborators
Lawson Health Research Institute
Medtronic

Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02757976     History of Changes
Other Study ID Numbers: 252410
First Posted: May 2, 2016    Key Record Dates
Last Update Posted: May 28, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Heart Failure
Ventricular Dysfunction
Ventricular Dysfunction, Left
Heart Diseases
Cardiovascular Diseases