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Difficulty recruiting
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This trial will compare two management strategies for HF patients with preserved LV function in sinus rhythm and LBBB. The control group will be treated with practice guideline optimal medical therapy for HF. The experimental group will be treated with CRT in addition to optimal medical therapy for HF. In addition, the trial will further compare two methods of delivering CRT. One experimental group will receive BiV-CRT, while the second experimental group will receive CS-CRT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | The control group will be treated with practice guideline optimal medical therapy for HF. | |
| BiV-CRT | Experimental | The experimental group will be treated with CRT in addition to optimal medical therapy for HF. In addition, the trial will further compare two methods of delivering CRT. One experimental group will receive BiV-CRT, while the second experimental group will receive Conduction System(CS)-CRT. |
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| CS-CRT | Experimental | The experimental group will be treated with CRT in addition to optimal medical therapy for HF. In addition, the trial will further compare two methods of delivering CRT. One experimental group will receive BiV-CRT, while the second experimental group will receive Conduction System(CS)-CRT. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRT | Device | The experimental group will be treated with CRT in addition to optimal medical therapy for HF. In addition, the trial will further compare two methods of delivering CRT. One experimental group will receive BiV-CRT, while the second experimental group will receive CS-CRT |
| Measure | Description | Time Frame |
|---|---|---|
| NTproBNP measurement | The co-primary outcome measure is NTproBNP as measured at 6 months. | 6 Months |
| 6-minute walk distance | The co-primary outcome measure is 6 minute hall walk distance as measured at 6 months. | 6 Months |
| Quality of Life (QoL) score | The co-primary outcome measure is quality of life as measured using the Minnesota Living with Heart Failure Questionnaire (MLHFQ) score. The MLHFQ consists of 21 questions answered on a 0-5 likert scale, with higher scores indicating a stronger impact of heart failure on QoL. | 6 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 | The secondary outcome measure is Ventricular arrhythmia burden determined by the device as measured at 6 months. | 6 Months |
| LV reverse remodeling (LVESVi on echocardiography) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Health Sciences Centre | London | Ontario | Canada |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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This is a multi-centre randomized controlled trial with a prospective randomized open blinded endpoint trial (PROBE) design.
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The secondary outcome measure is LV reverse remodeling as measured by LVESVi on echocardiography at 6 months. |
| 6 Months |
| LVEF | The secondary outcome measure is LVEF as measured by echocardiography at 6 months. | 6 Months |
| A composite of all-cause mortality and HF events | The secondary outcome measure a composite of all-cause mortality and HF events at 6 months. | 6 Months |
| Packer Composite Clinical Outcome Score | The secondary outcome measure is Packer Composite Clinical Outcome Score at 6 months. The Packer Clinical Composite Score classifies each patient into 1 of 3 categories (improved, worsened, unchanged), and is determined using clinical outcomes, heart failure status, and patient symptoms. Patients are considered improved if at the final visit they experienced in the patient assessment of a pre-specified scale but did not experience any major adverse clinical events throughout the trial. If considered worse, patients experienced a major clinical event during the planned duration of double-blind treatment or reported worsening at their final visit. And if considered unchanged, patients would be considered neither improved nor worse. | 6 Months |