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Consensus RAFT-LVendo Steering Committee to terminate.
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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional CRT | Device | 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. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Libin Cardiovascular Institute | Calgary | Alberta | Canada | |||
| Royal Columbia Hospital |
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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.
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| LV endocardial CRT | Device | 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. |
|
| 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 |
| 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 |
| New Westminster |
| British Columbia |
| Canada |
| Vancouver General Hospital | Vancouver | British Columbia | K4A 3B2 | Canada |
| Queen Elizabeth II Health Science | Halifax | Nova Scotia | Canada |
| London Health Science Centre | London | Ontario | Canada |
| University of Ottawa Heart Institute | Ottawa | Ontario | Canada |
| St. Michael Hospital | Toronto | Ontario | Canada |
| McGill University Health Centre | Montreal | Quebec | Canada |
| Montreal Heart Institute | Montreal | Quebec | Canada |
| Institut Univ.cardiologie/pneumologie de Québec | Québec | Quebec | Canada |
| CHUS Le Centre hospitalier universitaire de Sherbrooke | Sherbrooke | Quebec | Canada |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D018487 | Ventricular Dysfunction, Left |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D018754 | Ventricular Dysfunction |
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