Cardiac Hemodynamics During Left Ventricular Assist
ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRegion Östergötland
About this trial
The goal of this observational study is to exploratively investigate intracardiac geometry and hemodynamics in patients with ongoing HeartMate 3-therapy in the Swedish Southeast Healthcare region. The main question it aims to answer is:
\- How do different flow levels in the HeartMate 3 left ventricular assist system influence intracardiac geometry and hemodynamics?
Participating research subjects are called upon to undergo three followed photon-counting CT scans, as well as certain echocardiographic imaging, all in one session. The research subject's HeartMate device is connected to software that allows for variations in the pump's flow between these image collections. Analyzed variables includes three-dimensional geometry, CFD-computed parameters such as blood velocity, pressure, turbulence, and blood stasis. The variables are related with device settings and, alongside, selected echocardiographic measurements and patient details such as age, BMI, and diagnostic codes for both method validation and comprehensive perspective.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Connected to Linköping University Hospital ((situated in the Swedish Southeastern healthcare region)
Treatment with HeartMate 3 and implanted for > 6 months ago
Age >18 years.
Disqualifiers
Reduced kidney function (eGFR below 45 ml/min/1.73m2).
Known iodine contrast allergy
In case of untreated manifest hyperthyroidism
In case of suspected/newly diagnosed thyroid cancer where radioiodine examination/treatment may be relevant
Trial population
All HeartMate 3 patients within the Swedish Southeastern healthcare region, encompassing Östergötland, Jönköping, and Kalmar counties, who meet the inclusion criteria and none of the exclusion criteria, will be invited to participate in this study during 2023. Screening for inclusion is conducted by the LVAD-responsible physicians within the Cardiology Department at Linköping University Hospital.
Trial design
Design model
Case-only
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Hemodynamic Variables
Intracardiac hemodynamic variables such as blood flow velocity maps (m/s), absolute pressure maps (mmHg), turbulence kinetic energy maps (TKE), and blood stasis maps will be calculated both intracardiac and in the pump's outflow graft. It is essential to clarify that due to the exploratory nature of the research and the intricate dynamics inherent to both using numerical frameworks for calculating intracardiac hemodynamic maps and the dynamic geometric nature of time-resolved CT, all variables at the study onset are not pre-defined. As the analysis progresses, and the full depth of the data becomes apparent, additional variables may be identified and incorporated. Subsequent decision-making process relating to the inclusion or exclusion of these newly discovered variables will be rigorously documented to ensure transparency and robustness in the study approach.
Time frame
Observations are made at a single point in time. No follow-up of outcomes are analyzed. Post-processing and analysis of both hemodynamic and geometric data are performed through study completion, an average of 1 year.2
Intracardiac Geometry
Intracardiac volumes (ml) will be calculated for the left atrium, left ventricle, right ventricle and right atrium over the cardiac cycle (20 phases). It is essential to clarify that due to the exploratory nature of the research and the intricate dynamics inherent to both using numerical frameworks for calculating intracardiac hemodynamic maps and the dynamic geometric nature of time-resolved CT, all variables at the study onset are not pre-defined. As the analysis progresses, and the full depth of the data becomes apparent, additional variables may be identified and incorporated. Subsequent decision-making process relating to the inclusion or exclusion of these newly discovered variables will be rigorously documented to ensure transparency and robustness in the study approach.
Time frame
Observations are made at a single point in time. No follow-up of outcomes are analyzed. Post-processing and analysis of both hemodynamic and geometric data are performed through study completion, an average of 1 year.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Region Östergötland
Lead sponsor
Linkoeping University
Collaborator
Source ClinicalTrials.gov