---
title: Observational Hemodynamic Monitoring During LVAD Implantation Among Individuals With Advanced Heart Failure
nct_id: NCT03464981
overall_status: COMPLETED
sponsor: University of Colorado, Denver
study_type: OBSERVATIONAL
primary_condition: Heart Failure
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03464981.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03464981"
ct_last_update_post_date: 2020-09-25
last_seen_at: "2026-05-12T06:30:11.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Observational Hemodynamic Monitoring During LVAD Implantation Among Individuals With Advanced Heart Failure

**Official Title:** Observational Hemodynamic Monitoring During LVAD Implantation Among

**NCT ID:** [NCT03464981](https://clinicaltrials.gov/study/NCT03464981)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 20
- **Lead Sponsor:** University of Colorado, Denver
- **Conditions:** Heart Failure, Circulatory Disorders Postprocedural Complication, Cardiomyopathy, Congestive, Surgery
- **Start Date:** 2018-09-10
- **Completion Date:** 2020-07-01
- **CT.gov Last Update:** 2020-09-25

## 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

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Advanced HF patients scheduled to undergo LVAD implantation**

## Primary Outcomes

- **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.
- **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.
- **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.
- **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.
- **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.
- **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 Outcomes

- **Change in Right ventricular function** _(time frame: During LVAD implant and for 12-24 hours during ICU admission)_
- **Change in Brain blood flow** _(time frame: During LVAD implant and for 12-24 hours during ICU admission)_

## Locations (1)

- University of Colorado Hospital, Aurora, Colorado, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of colorado hospital|aurora|colorado|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03464981.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03464981*  
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