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| Name | Class |
|---|---|
| Thoratec Corporation | INDUSTRY |
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We propose to study a strategy empirically applied for the past 6 months at a high volume LVAD center (Vanderbilt Heart and Vascular Institute). This utilizes an ultra conservative device programming strategy to maximize battery longevity, avoid inappropriate implantable cardioverter defibrillator (ICD) therapy, improve quality of life through reduction in overall shock burden, and potentially avoid unnecessary device generator changes prior to transplant. Avoiding CIED (cardiac implantable electronic device) change out device procedures prior to transplant is desirable.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional ICD Programming | Active Comparator | ICD will be set to pre-LVAD settings post LVAD implant. |
|
| Ultra Conservative ICD Programming | Experimental | ICD will be set to ultra conservative settings post LVAD implant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultra Conservative ICD Programming | Other |
| ||
| Traditional ICD Programming |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first ICD shock following LVAD implant | Within 12 months following LVAD implant |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of anti-tachycardia pacing (ATP) therapy administration for appropriate or inappropriate arrhythmia detection | Number of ATP occurrences | Within 12 months following LVAD implant |
| Frequency of ICD generator change prior to definitive therapy |
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Inclusion:
Exclusion:
-Age < 18
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Ellis, MD | Vanderbilt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29475875 | Derived | Richardson TD, Hale L, Arteaga C, Xu M, Keebler M, Schlendorf K, Danter M, Shah A, Lindenfeld J, Ellis CR. Prospective Randomized Evaluation of Implantable Cardioverter-Defibrillator Programming in Patients With a Left Ventricular Assist Device. J Am Heart Assoc. 2018 Feb 23;7(5):e007748. doi: 10.1161/JAHA.117.007748. |
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| Other |
|
Number of patients requiring ICD generator change
| Within 12 months following LVAD implant |
| Cardiac implantable electronic device (CIED) battery voltage/estimated longevity changes | Battery voltage and battery life measured in days | Within 12 months following LVAD implant |
| Frequency of arrhythmic syncope | Number of syncope occurrences | Within 12 months following LVAD implant |
| Hospitalization frequency for decompensated congestive heart failure | Number of hospitalizations | Within 12 months following LVAD implant |
| Determine survival to heart transplantation following LVAD implant | Number of patients, post LVAD implant, to receive heart transplant and number of survival days post implant | Within 12 months following LVAD implant |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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