Clinical trial NCT03464981: Observational Hemodynamic Monitoring During LVAD Implantation Among Individuals With Advanced Heart Failure
Official title: Observational Hemodynamic Monitoring During LVAD Implantation Among
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Circulatory Disorders Postprocedural Complication
Cardiomyopathy, Congestive
Surgery
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2018-03-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility 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

Primary outcomes:
measure: Change in Cardiovascular hemodynamics (invasive and noninvasive)
timeFrame: During LVAD implant and for 12-24 hours during ICU admission
measure: Change in Heart Rate (HR)
timeFrame: During LVAD implant and for 12-24 hours during ICU admission
measure: Change in Blood Pressure (BP)
timeFrame: During LVAD implant and for 12-24 hours during ICU admission
measure: Change in Right Atrial (RA) pressure
timeFrame: During LVAD implant and for 12-24 hours during ICU admission
measure: Change in pulmonary pressure
timeFrame: During LVAD implant and for 12-24 hours during ICU admission
measure: Change in Cardiac output
timeFrame: During LVAD implant and for 12-24 hours during ICU admission
Secondary outcomes:
measure: Change in Right ventricular function
timeFrame: During LVAD implant and for 12-24 hours during ICU admission
measure: Change in Brain blood flow
timeFrame: During LVAD implant and for 12-24 hours during ICU admission
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Jay D Pal, MD
role: PRINCIPAL_INVESTIGATOR
References: