Status:
COMPLETED
Observational Hemodynamic Monitoring During LVAD Implantation Among Individuals With Advanced Heart Failure
Lead Sponsor:
University of Colorado, Denver
Conditions:
Heart Failure
Circulatory Disorders Postprocedural Complication
Eligibility:
All Genders
18+ years
Brief Summary
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 failur...
Eligibility Criteria
Inclusion
- individuals ≥ 18 years of age with severe heart failure (HF) and who have been approved by the advanced HF selection committee for LVAD implantation.
Exclusion
- 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:
- a right-atrial pressure (RAP): pulmonary capillary wedge pressure (PCWP) ratio of ≥ 0.67 (note: this index compares pressures on the right \[RAP\] and left \[PCWP\] side of the heart;
- an RAP/PCWP ratio ≥ 0.67 provides hemodynamic evidence of RV dysfunction.
- 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
Key Trial Info
Start Date :
September 10 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03464981
Start Date
September 10 2018
End Date
July 1 2020
Last Update
September 25 2020
Active Locations (1)
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1
University of Colorado Hospital
Aurora, Colorado, United States, 80045