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

NCT03464981 | Completed

• 1 other identifier: 17-2119
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Circulatory Disorders Postprocedural Complication; Cardiomyopathy, Congestive; Surgery

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• Change in Right ventricular function

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

• Change in Brain blood flow

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

Study Arms (1)

Advanced HF patients scheduled to undergo LVAD implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Heart Failure; Cardiomyopathy, Dilated

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Cardiomegaly; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Jay D Pal, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: March 14, 2018
• Study Start: September 10, 2018
• Primary Completion: June 1, 2020
• Study Completion: July 1, 2020
• Last Updated: September 25, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)