ClinicalTrials.gg
CompletedNCT04478890Updated Feb 4, 2025

Hemodynamic Assessment of the Right Ventricle Using Pressure-volume Loop Catheter and Pulmonary Artery Catheter in Patients Undergoing Left Ventricular Assist Device Placement

An observational study in Right Ventricular Dysfunction, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-04.

Sponsored by University of Minnesota · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
4
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Right Ventricular Dysfunction
03

In context

Ventricular Dysfunction, Right

90 studies on the registry are indexed under Ventricular Dysfunction, Right; 28 are open to participants now.

This study's enrollment of 4 is below the median of 100 across 51 observational studies indexed under Ventricular Dysfunction, Right.

Browse Ventricular Dysfunction, Right studies →

Lead sponsor

University of Minnesota is the lead sponsor of 1,216 studies on the registry; 197 are open to participants now.

Of its 136 completed or terminated interventional studies of FDA-regulated products, 95 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
4 participants (actual)
Patient registry
No

Groups and cohorts

  • Observational Group

    Characterize right ventricular function while undergoing LVAD implantation

    Diagnostic Test: Hemodynamic assessment

Interventions

  • Diagnostic testHemodynamic assessment

    Hemodynamic assessment of the right ventricle using pressure-volume loop catheter and pulmonary artery catheter

06

What researchers measure

Primary outcomes

  1. Stroke volume

    Stroke volume will be reported in units of millilitres per square metre

    Time frame: Approximately 4-6 hours

  2. Heart rate

    Heart rate will be reported in units of beats per minute

    Time frame: Approximately 4-6 hours

  3. Ejection fraction

    Ejection fraction will be reported as a percent

    Time frame: Approximately 4-6 hours

  4. Cardiac output

    Cardiac output will be reported in units of milliliters per minute

    Time frame: Approximately 4-6 hours

  5. End-systolic pressure

    End-systolic pressure will be reported in units of mmHG

    Time frame: Approximately 4-6 hours

  6. End-systolic volume

    End-systolic volume will be reported in units of milliliters

    Time frame: Approximately 4-6 hours

  7. End-diastolic pressure

    End-diastolic pressure will be reported in units of mmHG

    Time frame: Approximately 4-6 hours

  8. End-diastolic volume

    End-diastolic volume will be reported in units of milliliters

    Time frame: Approximately 4-6 hours

  9. Right ventricular dP/dt

    Right ventricular dP/dt will be reported in units of mmHg per second

    Time frame: Approximately 4-6 hours

  10. Stroke work

    Stroke work will be reported in units of gram meters (g\*m)

    Time frame: Approximately 4-6 hours

07

Study locations

1 site
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2021 to primary completion in Dec 2024, 40 months.

Of 25 observational studies under Ventricular Dysfunction, Right, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 26. This study's 40 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 15, 2020
First posted
Jul 21, 2020
StartActual
Aug 1, 2021
Primary completionActual
Dec 31, 2024
CompletionActual
Dec 31, 2024
Last update
Feb 4, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04478890
Responsible party
Sponsor
First posted
Jul 21, 2020
Start date
Aug 1, 2021
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024
Last update
Feb 4, 2025

Study contacts

Tjorvi Perry, MD, MMSc
principal investigator · University of Minnesota

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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