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

Heart Failure

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

Plain Language Summary

Simplified for easier understanding

This study examines how the heart works in patients who have a left ventricular assist device (LVAD) — a mechanical pump implanted to help a failing heart pump blood. Researchers at Linköping University Hospital in Sweden will use advanced heart imaging to better understand how these devices affect heart function. **You may be eligible if:** - You are a patient at Linköping University Hospital (Sweden) - You have had a HeartMate 3 LVAD implanted for more than 6 months - You are 18 or older **You may NOT be eligible if:** - You have poor kidney function (eGFR below 45) - You have an allergy to iodine contrast dye - You have untreated overactive thyroid (hyperthyroidism) - You have suspected thyroid cancer where radioiodine testing may be needed - You have myasthenia gravis - You have other ongoing conditions that could affect the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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