RecruitingNCT06115096

Cardiac Hemodynamics During Left Ventricular Assist

Exploration of Intracardiac Geometry and Hemodynamics During HeartMate 3 Therapy: A Novel Approach Using Photon-Counting CT and Computational Fluid Dynamics


Sponsor

Region Östergötland

Enrollment

35 participants

Start Date

Mar 1, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria3

  • 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.

Exclusion Criteria6

  • 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
  • Myasthenia Gravis
  • Ongoing pregnancy

Locations(1)

Linköping University Hospital

Linköping, Östergötland County, Sweden

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NCT06115096


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