Actively Recruiting

Age: 18Years +
All Genders
NCT06115096

Cardiac Hemodynamics During Left Ventricular Assist

Led by Region Östergötland · Updated on 2023-11-02

35

Participants Needed

1

Research Sites

356 weeks

Total Duration

On this page

Sponsors

R

Region Östergötland

Lead Sponsor

L

Linkoeping University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Cardiac Hemodynamics During Left Ventricular Assist

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Connected to Linköping University Hospital in the Swedish Southeastern healthcare region
  • Treatment with HeartMate 3 implanted more than 6 months ago
  • Age over 18 years
Not Eligible

You will not qualify if you...

  • Reduced kidney function (eGFR below 45 ml/min/1.73m2)
  • Known allergy to iodine contrast
  • Untreated manifest hyperthyroidism
  • Suspected or newly diagnosed thyroid cancer where radioiodine examination or treatment may be needed
  • Diagnosis of Myasthenia Gravis
  • Ongoing pregnancy

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Linköping University Hospital

Linköping, Östergötland County, Sweden, 58185

Actively Recruiting

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Research Team

H

Hans Granfeldt, MD/PhD

CONTACT

L

Linus Ohlsson, PhD-student

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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