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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Sweden
Linköping University Hospital
RECRUITING
Linköping
Contact Information
Primary
Hans Granfeldt, MD/PhD
hans.granfeldt@regionostergotland.se
010-103 00 00
Backup
Linus Ohlsson, PhD-student
linus.ohlsson@regionostergotland.se
010-103 00 00
Time Frame
Start Date: 2023-03-01
Estimated Completion Date: 2030-01-01
Participants
Target number of participants: 35
Related Therapeutic Areas
Sponsors
Collaborators: Linkoeping University
Leads: Region Östergötland

This content was sourced from clinicaltrials.gov