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The purpose of this study is to demonstrate that cardiac resynchronization therapy (CRT) responder rate can be improved by 3-dimensional (3D) echo-guided left ventricular (LV) lead placement compared to traditional LV lead placement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | Patients will be implanted according to the standard of care with the LV lead in the traditional LV lead position. | |
| 3D echo-guided LV lead placement group | Experimental | Information about left ventricular mechanical dyssynchrony and the location of the site of latest mechanical activation based on Real-Time 3-Dimensional Echocardiography (RT3DE) will be available to the physician at the time of implant. This location will be used as the target for optimal LV lead placement. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D echo-guided LV lead placement | Procedure | Information about left ventricular mechanical dyssynchrony and the location of the site of latest mechanical activation based on RT3DE will be available to the physician from the core lab analysis. This location will be used as the target for optimal LV lead placement. |
| Measure | Description | Time Frame |
|---|---|---|
| Responder Rate | The responder rate is defined as the proportion of patients with reduction in end systolic volume greater than or equal to 15%. The primary endpoint is the responder rate. | At 6 month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Heart Group | Nashville | Tennessee | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 3D Echo-guided LV Lead Placement | The location of the site of latest mechanical activation based on 3-D Echo will be available to the physician from the core lab analysis. This location will be used as the target for optimal Left Ventricular lead placement. |
| FG001 | Control |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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Patients will be implanted according to the standard of care with the Left Ventricular lead in the traditional Left Ventricular lead position. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 3D Echo-guided LV Lead Placement | The location of the site of latest mechanical activation based on 3-D Echo will be available to the physician from the core lab analysis. This location will be used as the target for optimal Left Ventricular lead placement. |
| BG001 | Control | Patients will be implanted according to the standard of care with the Left Ventricular lead in the traditional Left Ventricular lead position. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Responder Rate | The responder rate is defined as the proportion of patients with reduction in end systolic volume greater than or equal to 15%. The primary endpoint is the responder rate. | Patients who completed the 6 month follow-up with implant 3D echo data. | Posted | Number | percentage of participants | At 6 month follow-up |
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6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 3D Echo-guided LV Lead Placement | The location of the site of latest mechanical activation based on 3-D Echo will be available to the physician from the core lab analysis. This location will be used as the target for optimal Left Ventricular lead placement. | 0 | 43 | 1 | 43 | ||
| EG001 | Control | Patients will be implanted according to the standard of care with the Left Ventricular lead in the traditional Left Ventricular lead position. | 0 | 35 | 1 | 35 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | Systematic Assessment |
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| Pericardial Effusion | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Gill | St. Jude Medical | 818-493-2609 | jgill@sjm.com |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| >=65 years |
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| Male |
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