Heart Failure Clinical Trial

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

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 failure - specifically, how right ventricular function is compromised as a result of LVAD implantation.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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 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:

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

Study is for people with:

Heart Failure

Estimated Enrollment:

20

Study ID:

NCT03464981

Recruitment Status:

Completed

Sponsor:

University of Colorado, Denver

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There is 1 Location for this study

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University of Colorado Hospital
Aurora Colorado, 80045, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

20

Study ID:

NCT03464981

Recruitment Status:

Completed

Sponsor:


University of Colorado, Denver

How clear is this clinincal trial information?

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