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The overall objective of this pilot analysis is to characterize the hemodynamic changes that occur during implantation of a left ventricular assist device (LVAD) in patients with advanced heart failure - specifically, how right ventricular function is compromised as a result of LVAD implantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Advanced HF patients scheduled to undergo LVAD implantation |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Cardiovascular hemodynamics (invasive and noninvasive) | Cardiovascular hemodynamics will be measured both invasively and noninvasively as standard-of-care during LVAD implantation in the Operating Room (OR), and immediately afterwards in the CT-ICU unit prior to discharge. | During LVAD implant and for 12-24 hours during ICU admission |
| Change in Heart Rate (HR) | Changes in HR will be evaluated during LVAD implantation in the OR, and immediately afterwards in the CT-ICU unit prior to discharge. | During LVAD implant and for 12-24 hours during ICU admission |
| Change in Blood Pressure (BP) | Changes in BP will be evaluated during LVAD implantation in the OR, and immediately afterwards in the CT-ICU unit prior to discharge. | During LVAD implant and for 12-24 hours during ICU admission |
| Change in Right Atrial (RA) pressure | Changes in RA pressure will be evaluated during LVAD implantation in the OR, and immediately afterwards in the CT-ICU unit prior to discharge. | During LVAD implant and for 12-24 hours during ICU admission |
| Change in pulmonary pressure | Pulmonary pressure changes will be evaluated during LVAD implantation in the OR, and immediately afterwards in the CT-ICU unit prior to discharge. | During LVAD implant and for 12-24 hours during ICU admission |
| Change in Cardiac output | Cardiac output changes will be evaluated during LVAD implantation in the OR, and immediately afterwards in the CT-ICU unit prior to discharge. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Right ventricular function | Right ventricular function will be evaluated during LVAD implantation in the OR, and immediately afterwards in the CT-ICU unit prior to discharge. | During LVAD implant and for 12-24 hours during ICU admission |
| Change in Brain blood flow |
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Inclusion Criteria:
Exclusion Criteria:
Patients with pre-existing right ventricular (RV) dysfunction/failure, defined as:
Imaging evidence of moderate-severe RV dysfunction on echocardiography
Hemodynamic evidence of RV dysfunction with:
Clinical evidence of preexisting RV dysfunction, as indicated by significant (3-4+ peripheral edema) and/or elevated jugular venous pressures on clinical examination.
Patients with end-stage renal disease requiring hemodialysis
Patients requiring temporary hemodynamic support prior to LVAD implantation with temporary LVADs, and/or veno-arterial extracorporeal membrane oxygenators ("ECMO").
Planned concurrent implantation of right ventricular assist device
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Patients with advanced HF who are scheduled to undergo LVAD implantation with either the Heartmate 2, Heartmate 3 (Abbott, Abbott Park, IL) or HVAD (Medtronic, Minneapolis, MD) LVADs
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| Name | Affiliation | Role |
|---|---|---|
| Jay D Pal, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D002311 | Cardiomyopathy, Dilated |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006332 | Cardiomegaly |
| D009202 | Cardiomyopathies |
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| During LVAD implant and for 12-24 hours during ICU admission |
Brain blood flow will be evaluated during LVAD implantation in the OR, and immediately afterwards in the CT-ICU unit prior to discharge. |
| During LVAD implant and for 12-24 hours during ICU admission |
| D000083083 |
| Laminopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |