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| ID | Type | Description | Link |
|---|---|---|---|
| 7314 |
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| Name | Class |
|---|---|
| Abbott Medical Devices | INDUSTRY |
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The purpose of this study is to determine whether using an echocardiogram (a painless test where ultrasound is used to see your heart) while using mild electrical stimulation from your own CRT-D device to stimulate the ventricles (the lower chambers of the heart) to squeeze one slightly earlier than the other will show a sustained increase your heart's productivity (Cardiac Output (CO)), following implantation of a Cardiac Resynchronization Device (CRT-D). We believe that squeezing some parts of the heart earlier than others may make the heart a stronger pump.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Echocardiographically guided optimized device programming: specifically sequential BiV pacing. "Sequential Arm" |
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| 2 | Active Comparator | Simultaneous BiV pacing. "Simultaneous Arm" |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "Sequential Arm" (Promote , model # 2207-36 or Atlas HF , model # V-343) | Other | Echocardiographically guided optimized device programming: specifically sequential BiV pacing. "Sequential Arm" Using one of the FDA approved St. Jude devices, depending on MD preference. |
| Measure | Description | Time Frame |
|---|---|---|
| To determine if a sustained hemodynamic benefit of increased Cardiac Output is maintained in patients who undergo ECHO guided optimization of V-V timing following CRT implantation when compared to patients simultaneously biventricularly paced. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment for improvements in 1)6 minute walk 2)ECHO parameters 3)symptoms as assessed by the Minnesota Quality of Life Score. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hranitzky Patrick, MD | Duke University | Principal Investigator |
| Patrick Hranitzky, MD | Duke University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
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| "Simultaneous Arm" (Promote , model # 2207-36 or Atlas HF , model # V-343) | Other | simultaneous BiV pacing. Using one of the FDA approved St. Jude devices, depending on MD preference. |
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| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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