NCT06115096Recruiting
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
Source: ClinicalTrials.gov · Last updated 2 Nov 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 35 (estimated)
- First submitted
- 16 Oct 2023
- Start date
- 1 Mar 2023
- Primary completion date
- 1 Jan 2030
- Lead sponsor
- Region Östergötland
- Diseases
- Heart failure
- NCT number
- NCT06115096
What you commit to
- Study type: Observational
- Planned participants: 35
- From 1 Mar 2023 to the primary completion date, 1 Jan 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known iodine contrast allergy
- In case of suspected/newly diagnosed thyroid cancer where radioiodine examination/treatment may be relevant
Lab values
- Reduced kidney function (eGFR below 45 ml/min/1.73m2).
Other
- In case of untreated manifest hyperthyroidism
- Myasthenia Gravis
- Ongoing pregnancy
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Linkoping University Hospital Coordinator of this site? Confirm its status | Linköping | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.