Observational Hemodynamic Monitoring During LVAD Implantation Among Individuals With Advanced Heart Failure

Completed

Conditions studied: Heart Failure, Circulatory Disorders Postprocedural Complication, Cardiomyopathy, Congestive, Surgery

In brief

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.

Key facts

Study ID

NCT03464981

Run by

University of Colorado, Denver

People needed

20

Starts

2018-09-10

Expected to finish

2020-07-01

Last updated by the study team

2020-09-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• individuals ≥ 18 years of age with severe heart failure (HF) and who have been approved by the advanced HF selection committee for LVAD implantation.

You may not qualify if…

• 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

Where it is running

• University of Colorado Hospital — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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