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

Completed

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

• Registration Number: NCT03464981
• Lead Sponsor: University of Colorado, Denver

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-05
• Study First Submitted QC: 2018-03-12
• Study First Posted: 2018-03-14
• Study Start: 2018-09-10
• Primary Completion: 2020-06-01
• Study Completion: 2020-07-01
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-24
• Last Update Posted: 2020-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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:

  1. Imaging evidence of moderate-severe RV dysfunction on echocardiography

  2. 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.

  3. Clinical evidence of preexisting RV dysfunction, as indicated by significant (3-4+ peripheral edema) and/or elevated jugular venous pressures on clinical examination.

  4. Patients with end-stage renal disease requiring hemodialysis

  5. Patients requiring temporary hemodynamic support prior to LVAD implantation with temporary LVADs, and/or veno-arterial extracorporeal membrane oxygenators ("ECMO").

  6. Planned concurrent implantation of right ventricular assist device

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in pulmonary pressure	During LVAD implant and for 12-24 hours during ICU admission	Pulmonary pressure changes will be evaluated during LVAD implantation in the OR, and immediately afterwards in the CT-ICU unit prior to discharge.
Change in Cardiac output	During LVAD implant and for 12-24 hours during ICU admission	Cardiac output changes will be evaluated during LVAD implantation in the OR, and immediately afterwards in the CT-ICU unit prior to discharge.
Change in Cardiovascular hemodynamics (invasive and noninvasive)	During LVAD implant and for 12-24 hours during ICU admission	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.
Change in Heart Rate (HR)	During LVAD implant and for 12-24 hours during ICU admission	Changes in HR will be evaluated during LVAD implantation in the OR, and immediately afterwards in the CT-ICU unit prior to discharge.
Change in Right Atrial (RA) pressure	During LVAD implant and for 12-24 hours during ICU admission	Changes in RA pressure will be evaluated during LVAD implantation in the OR, and immediately afterwards in the CT-ICU unit prior to discharge.
Change in Blood Pressure (BP)	During LVAD implant and for 12-24 hours during ICU admission	Changes in BP will be evaluated during LVAD implantation in the OR, and immediately afterwards in the CT-ICU unit prior to discharge.

Secondary Outcome Measures

Name	Time	Method
Change in Right ventricular function	During LVAD implant and for 12-24 hours during ICU admission	Right ventricular function will be evaluated during LVAD implantation in the OR, and immediately afterwards in the CT-ICU unit prior to discharge.
Change in Brain blood flow	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.

Trial Locations

Locations (1)

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States