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

Observational Hemodynamic Monitoring During LVAD Implantation Among

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Advanced HF patients scheduled to undergo LVAD implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.	During LVAD implant and for 12-24 hours during ICU admission

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Jay D Pal, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 10, 2018
• Primary Completion (ACTUAL): June 1, 2020
• Study Completion (ACTUAL): July 1, 2020

Study Registration Dates

• First Submitted: February 5, 2018
• First Submitted That Met QC Criteria: March 12, 2018
• First Posted (ACTUAL): March 14, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 25, 2020
• Last Update Submitted That Met QC Criteria: September 24, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Genetic Diseases, Inborn; Cardiomegaly; Laminopathies; Heart Failure; Cardiomyopathies; Cardiomyopathy, Dilated
• Other Study ID Numbers: 17-2119

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No