Right Ventricular DysfunctionNCT04478890
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 of Right Ventricular Dysfunction, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Right Ventricular Dysfunction
- What is being tested?
- Hemodynamic assessment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2021to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients 18 years or older undergoing left ventricular assist device (LVAD) placement at the University of Minnesota Medical Center
Who may be able to join
- Patients undergoing left ventricular assist device (LVAD) placement at the University of Minnesota Medical Center
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
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
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.
- Conditions
- Right Ventricular Dysfunction
- Being tested
- Hemodynamic assessment
- Medical subject headings
- Ventricular Dysfunction, Right
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemodynamic assessmentDiagnostic test
Hemodynamic assessment of the right ventricle using pressure-volume loop catheter and pulmonary artery catheter
| Study group | Role | What they receive |
|---|---|---|
| Observational Group | Characterize right ventricular function while undergoing LVAD implantation Receives: Diagnostic Test: Hemodynamic assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke volume
Stroke volume will be reported in units of millilitres per square metre
Measured: Approximately 4-6 hours
Heart rate
Heart rate will be reported in units of beats per minute
Measured: Approximately 4-6 hours
Ejection fraction
Ejection fraction will be reported as a percent
Measured: Approximately 4-6 hours
Cardiac output
Cardiac output will be reported in units of milliliters per minute
Measured: Approximately 4-6 hours
End-systolic pressure
End-systolic pressure will be reported in units of mmHG
Measured: Approximately 4-6 hours
End-systolic volume
End-systolic volume will be reported in units of milliliters
Measured: Approximately 4-6 hours
End-diastolic pressure
End-diastolic pressure will be reported in units of mmHG
Measured: Approximately 4-6 hours
End-diastolic volume
End-diastolic volume will be reported in units of milliliters
Measured: Approximately 4-6 hours
Right ventricular dP/dt
Right ventricular dP/dt will be reported in units of mmHg per second
Measured: Approximately 4-6 hours
Stroke work
Stroke work will be reported in units of gram meters (g*m)
Measured: Approximately 4-6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start1 Aug 2021
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Right Ventricular DysfunctionStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tjorvi Perry, MD, MMSc, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04478890
- Sponsor's protocol ID
- ANES-2020-28725
- Status last verified
- Feb 2025
- First submitted
- 15 Jul 2020
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04478890
- Acronym / sponsor ID
- ANES-2020-28725
- Conditions
- Right Ventricular Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 21 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational Group | – | Diagnostic Test: Hemodynamic assessmentCharacterize right ventricular function while undergoing LVAD implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients 18 years or older undergoing left ventricular assist device (LVAD) placement at the University of Minnesota Medical Center
Key inclusion criteria (1 listed)
- Patients undergoing left ventricular assist device (LVAD) placement at the University of Minnesota Medical Center
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemodynamic assessmentHemodynamic assessment of the right ventricle using pressure-volume loop catheter and pulmonary artery catheter | Diagnostic test | Observational Group |
Primary outcome
Stroke volume
Time frame: Approximately 4-6 hours
Stroke volume will be reported in units of millilitres per square metre
Heart rate
Time frame: Approximately 4-6 hours
Heart rate will be reported in units of beats per minute
Ejection fraction
Time frame: Approximately 4-6 hours
Ejection fraction will be reported as a percent
Cardiac output
Time frame: Approximately 4-6 hours
Cardiac output will be reported in units of milliliters per minute
End-systolic pressure
Time frame: Approximately 4-6 hours
End-systolic pressure will be reported in units of mmHG
End-systolic volume
Time frame: Approximately 4-6 hours
End-systolic volume will be reported in units of milliliters
End-diastolic pressure
Time frame: Approximately 4-6 hours
End-diastolic pressure will be reported in units of mmHG
End-diastolic volume
Time frame: Approximately 4-6 hours
End-diastolic volume will be reported in units of milliliters
Right ventricular dP/dt
Time frame: Approximately 4-6 hours
Right ventricular dP/dt will be reported in units of mmHg per second
Stroke work
Time frame: Approximately 4-6 hours
Stroke work will be reported in units of gram meters (g*m)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
Related trials for Right Ventricular Dysfunction
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tjorvi Perry, MD, MMSc principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Right Ventricular Dysfunction, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke volume (time frame: Approximately 4-6 hours). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.