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| Name | Class |
|---|---|
| Main Line Health | OTHER |
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The purpose of this study is to determine if optimal lead placement, guided by the largest improvement in aortic flow measured by Doppler will:
The hypothesis of this study determines if response to CRT therapy could be improved by optimizing LV lead position at the time of the left ventricular pacing lead implantation. This optimization (using a Doppler wire) would alter the left ventricular activation pattern and contraction mechanics. This increase in contractility may improve the likelihood of mid/long term response to therapy. This study will compare 6-month response to CRT (left ventricular ejection fraction, decrease in left ventricular end systolic and end diastolic dimensions and volumes) in heart failure patients.
The secondary objective will be to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hemodynamicaly guided LV lead placement | Experimental | optimized left ventricular lead placement |
|
| Standard lead placement | Active Comparator | Standard LV lead placement with no measurements to guide LV lead placement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doppler flow measurement | Procedure | use of doppler wire to measure change in flow that corresponds to changes in stroke volume to guide LV lead placement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Left Ventricular End Systolic Volume (LVESV) using the difference from baseline to six months | Comparison of clinical and functional outcomes of stroke volume optimized lead placement to standard lateral lead placement. | Six months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in End diastolic volume | End diastolic volume should decrease over follow up time of six months as a result of left ventricular remodeling. | Six months |
| Change in ejection fraction | Increase in ejection fraction should happen as a result of remodeling and increased efficiency of the left ventricle |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dusan Kocovic, MD | Lankenau Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lankenau Hosspital | Wynnewood | Pennsylvania | 19096 | United States |
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| ID | Term |
|---|---|
| D002311 | Cardiomyopathy, Dilated |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006332 | Cardiomegaly |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D009202 | Cardiomyopathies |
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| standard implantation of the LV lead | Procedure | Standard implantation of the LV lead with measurements of flow |
|
| six months |
| Increase in exercise capacity | Inrease in exercise capacity should be result of remodeled left ventricle and increased stroke volume and cardiac output | six months |
| Decrease in heart failure related hospital admissions | number of hospitalizations for CHF should decrease during follow up | six months |
| D000083083 |
| Laminopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |