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

• ClinicalTrials.gov Identifier: NCT03464981
• Recruitment Status: Completed
• First Posted: March 14, 2018
• Last Update Posted: September 25, 2020
• Sponsor: University of Colorado, Denver
• Information provided by (Responsible Party): University of Colorado, Denver

Study Description

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.

Condition or disease
Heart Failure; Circulatory Disorders Postprocedural Complication; Cardiomyopathy, Congestive; Surgery

Study Design

• Study Type: Observational
• Actual Enrollment: 20 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Observational Hemodynamic Monitoring During LVAD Implantation Among
• Actual Study Start Date: September 10, 2018
• Actual Primary Completion Date: June 1, 2020
• Actual Study Completion Date: July 1, 2020

Groups and Cohorts

Group/Cohort
Advanced HF patients scheduled to undergo LVAD implantation

Outcome Measures

Primary Outcome Measures :

1. Change in Cardiovascular hemodynamics (invasive and noninvasive) [ Time Frame: 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.
2. Change in Heart Rate (HR) [ Time Frame: 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.
3. Change in Blood Pressure (BP) [ Time Frame: 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.
4. Change in Right Atrial (RA) pressure [ Time Frame: 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.
5. Change in pulmonary pressure [ Time Frame: 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.
6. Change in Cardiac output [ Time Frame: 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.

Secondary Outcome Measures :

1. Change in Right ventricular function [ Time Frame: 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.
2. Change in Brain blood flow [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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

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:

  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

Contacts and Locations

Locations

United States, Colorado

University of Colorado Hospital

Aurora, Colorado, United States, 80045

Sponsors and Collaborators

University of Colorado, Denver

Investigators

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

More Information

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT03464981
• Other Study ID Numbers: 17-2119
• First Posted: March 14, 2018
• Last Update Posted: September 25, 2020
• Last Verified: September 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Heart Failure; Cardiomyopathies; Cardiomyopathy, Dilated; Heart Diseases; Cardiovascular Diseases; Cardiomegaly; Laminopathies; Genetic Diseases, Inborn