Clinical trial NCT04478890: Hemodynamic Assessment of the Right Ventricle Using Pressure-volume Loop Catheter and Pulmonary Artery Catheter in Patients Undergoing Left Ventricular Assist Device Placement
Official title: Hemodynamic Assessment of the Right Ventricle Using Pressure-volume Loop Catheter and Pulmonary Artery Catheter in Patients Undergoing Left Ventricular Assist Device Placement at the University of Minnesota Medical Center
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Right Ventricular Dysfunction
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2020-07-21
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All consecutive patients 18 years or older undergoing left ventricular assist device (LVAD) placement at the University of Minnesota Medical Center

Brief summary: This study will include the placement of a pressure volume (PV) loop catheter in the right atrium of patients undergoing left ventricular assist device (LVAD) placement and measure relevant PV loop data. Transesophageal echocardiography (TEE) and pulmonary artery (PA) catheter parameters as comparators to the PV loop will be recorded.

Detailed description: This will be a prospective observational study design to characterize right ventricular function in 5 consecutive patients undergoing LVAD implantation at the University of Minnesota Medical Center (UMMC). Pre-, intra- and postoperative care delivery to all enrolled and consented patients will meet the standards of care otherwise delivered to patients undergoing LVAD implantation at UMMC; care delivery will be at the discretion of the clinical care team and will not be altered based on the output of the right ventricular high-fidelity conductance catheters.

Eligibility criteria: Inclusion Criteria:

- Patients undergoing left ventricular assist device (LVAD) placement at the University of Minnesota Medical Center

Exclusion Criteria:

* Patients with a history of internal jugular vein thrombosis or known reasons for not being able to thread a central venous catheter through either internal jugular vein
* Patients with a history of known esophageal strictures, esophageal or stomach cancer, esophageal varices, or any patient in whom a TEE is contraindicated
* Patients with permanent pacemakers whose right ventricle is being paced and not in normal sinus rhythm
* Patients unable to consent to participating in the study
* Patients who are pregnant will be excluded, as part of standard care, all female patients are screened for pregnancy prior to surgery.

Primary outcomes:
measure: Stroke volume
timeFrame: Approximately 4-6 hours
measure: Heart rate
timeFrame: Approximately 4-6 hours
measure: Ejection fraction
timeFrame: Approximately 4-6 hours
measure: Cardiac output
timeFrame: Approximately 4-6 hours
measure: End-systolic pressure
timeFrame: Approximately 4-6 hours
measure: End-systolic volume
timeFrame: Approximately 4-6 hours
measure: End-diastolic pressure
timeFrame: Approximately 4-6 hours
measure: End-diastolic volume
timeFrame: Approximately 4-6 hours
measure: Right ventricular dP/dt
timeFrame: Approximately 4-6 hours
measure: Stroke work
timeFrame: Approximately 4-6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Tjorvi Perry, MD, MMSc
role: PRINCIPAL_INVESTIGATOR
References: