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Cardiac resynchronization therapy (CRT) or biventricular pacing is a useful treatment for heart failure and those suffering from arrhythmias. The purpose of this research study is to determine the effect left-ventricular pacing has on patients who have a ventricular assist device.
As part of the study participation the following two visits will be completed as listed below.
Baseline Visit: The following procedures will be conducted at this visit:
Regularly Scheduled Clinic Visit: At the next regularly scheduled Left Ventricular Assist Devices (LVAD) clinic visit, approximately 4 weeks after the baseline visit, the following procedures will be done:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LVAD CRT | The following procedures will be performed: limited echocardiogram, an adjustment to the CRT device's programmed settings, follow-up in 30 days to adjust the CRT device's programmed settings. In addition, quality of life questionnaires will be filled out and a 6 minute walk test will be completed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LVAD CRT | Device | The following procedures will be performed: limited echocardiogram, an adjustment to the CRT device's programmed settings, follow-up in 30 days to adjust the CRT device's programmed settings. In addition, quality of life questionnaires will be filled out and a 6 minute walk test will be completed. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in echocardiographic parameters | A comparison of the echocardiogram completed at enrollment and at 30 days. | Change in baseline to 30 days |
| 6 minute walk distance | A trained staff member will supervise participants in the completion of a 6 minute walk test. They will be instructed to walk on a level surface, on a clearly marked indoor course. heart rate and oxygen level will be monitored. The total distance completed at the end of 6 minutes will be noted. | Change in baseline to 30 days |
| Quality of Life | A comparison of the questionnaires completed at enrollment and at 30 days. | Change in baseline to 30 days |
| Number of Ventricular Tachycardia Episodes | At baseline and again at 30 days CRT device interrogation will be done to count the number of ventricular tachycardia episodes with LV pacing on and off. | Change in baseline to 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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Adults with ventricular dysfunction, dyssynchrony, functional capacity presence of arrhythmia. LVAD patients undergo 6 minute walk testing and complete a quality of life questionnaire routinely as part of their care on our LVAD clinic. Additionally, periodic echcoardiography is obtained to determine LVAD dynamics and ventrocular dimensions. We will utilize this information for our study, as well as information from their cardiac resynchronization devices, which is part of routine care for patietns with pacemakers and defibrillators.
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| Name | Affiliation | Role |
|---|---|---|
| Mustafa Ahmed, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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