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

Heart Failure Clinical Trial

— BATMAN  

Official title:

Observational Hemodynamic Monitoring During LVAD Implantation Among

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03464981
• Other study ID #: 17-2119
• Status: Completed
• Start date: September 10, 2018
• Est. completion date: July 1, 2020

Study information

• Verified date: September 2020
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Congestive
• Cardiomyopathy, Dilated
• Circulatory Disorders Postprocedural Complication
• Heart Failure
• Surgery

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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