Investigating heart function in patients with a HeartMate 3 device
Exploration of Intracardiac Geometry and Hemodynamics During HeartMate 3 Therapy: A Novel Approach Using Photon-Counting CT and Computational Fluid Dynamics
This study is testing how changing the flow levels in the HeartMate 3 device affects heart function and blood flow in patients with heart failure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 35 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Region Östergötland Academic / other |
| Locations | 1 site (Linköping, Östergötland County) |
| Trial ID | NCT06115096 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore how different flow levels in the HeartMate 3 left ventricular assist device affect intracardiac geometry and hemodynamics in patients with heart failure. Participants will undergo three photon-counting CT scans and echocardiographic imaging in a single session, while their HeartMate device's flow is varied. The study will analyze three-dimensional geometry and computational fluid dynamics parameters, including blood velocity and pressure, in relation to device settings and patient characteristics. The findings could enhance understanding of cardiac function during mechanical circulatory support.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who have been treated with the HeartMate 3 device for more than six months.
Not a fit: Patients with reduced kidney function, known iodine contrast allergy, untreated hyperthyroidism, or certain other medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management of heart failure patients using the HeartMate 3 device.
How similar studies have performed: While the use of advanced imaging techniques in this context is relatively novel, previous studies have shown promise in improving hemodynamic monitoring in heart failure patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Reduced kidney function (eGFR below 45 ml/min/1.73m2). * Known iodine contrast allergy * In case of untreated manifest hyperthyroidism * In case of suspected/newly diagnosed thyroid cancer where radioiodine examination/treatment may be relevant * Myasthenia Gravis * Ongoing pregnancy
Where this trial is running
Linköping, Östergötland County
- Linköping University Hospital — Linköping, Östergötland County, Sweden (Recruiting)
Study contacts
- Principal investigator: Hans Granfeldt, MD/PhD — Region Östergötland
- Study coordinator: Hans Granfeldt, MD/PhD
- Email: hans.granfeldt@regionostergotland.se
- Phone: 010-103 00 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.