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Imaging Heart Shape and Blood Flow During Heart Pump Support

Studies how heart pump flow levels affect heart shape and blood flow in heart failure.

Plain-language title generated from the registry record
Registry title: Cardiac Hemodynamics During Left Ventricular Assist

Key facts

Where
Linköping, SwedenSee the site

Where in Sweden

  • Linkoping University HospitalLinköping, SwedenTaking people

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Trial details

Who runs it
Region Östergötland
Trial code
NCT06115096
Record updated
2 November 2023
Original description
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:Read full original descriptionShow less

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

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.

Inclusion: 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: Known iodine contrast allergy; In case of suspected/newly diagnosed thyroid cancer where radioiodine examination/treatment may be relevant; Reduced kidney function (eGFR below 45 ml/min/1.73m2); In case of untreated manifest hyperthyroidism; Myasthenia Gravis; Ongoing pregnancy.

ClinicalTrials.gov NCT06115096