Investigating heart function in patients with a HeartMate 3 device

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.