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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
| Lexington VA Medical Center | FED |
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The primary objective is to determine if lead positioning in the lateral wall of the left ventricle in patients meeting criteria for cardiac resynchronization therapy plays a role in determining myocardial function and affects the severity of mitral regurgitation.
This is a 6 month, multi-centered, blinded, randomized study. Approximately 60 patients will join this study. Two groups, based on lead position, will be studied with thirty (30) patients randomized into each group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Postero-lateral | Active Comparator | Left ventricular lateral wall lead position |
|
| Antero-lateral | Active Comparator | Left ventricular lateral wall lead position |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Postero-lateral | Procedure | A device implant procedure will be performed under the standard of care technique with the right ventricular lead at the right ventricular apex and the left ventricular lead targeting or postero-lateral area of the LV based on pre-procedure randomization. |
| Measure | Description | Time Frame |
|---|---|---|
| Change (reduction) in left ventricular end systolic volume (LVESV) | 3 and 6 months | |
| Change in 6 minute walk tests | 6 weeks, 3 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial performance as measured by myocardial performance index (MPI) | 6 months | |
| Papillary muscle velocity as determined by tissue doppler | 6 months | |
| Progression of mitral regurgitation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sergio Thal, M.D. | Contact | 520-792-1450 | 4624 | sergio.thal@va.gov |
| Elizabeth Juneman, M.D. | Contact | 520-792-1450 | 4624 | elizabeth.juneman@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Sergio Thal, M.D. | Southern Arizona VA Health Care System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern Arizona VA Health Care System | Recruiting | Tucson | Arizona | 85723 | United States |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| Antero-Lateral | Procedure | A device implant procedure will be performed under the standard of care technique with the right ventricular lead at the right ventricular apex and the left ventricular lead targeting or antero-lateral area of the LV based on pre-procedure randomization. |
|
as measured by regurgitant volume, mitral regurgitation fraction and effective regurgitant orifice area |
| 6 months |
| Minnesota living heart failure survey | 6 weeks, 3 and 6 months |
| Chronic heart failure hospitalizations | Monitored during study participation ~ 6 months |
| Lexington VA Medical Center | Recruiting | Lexington | Kentucky | 40502 | United States |
|