Noninvasive Cardiovascular Diagnosis of Patients With Fully Magnetically Levitated Blood Pumps

Launched by THOMAS SCHLÖGLHOFER · Nov 20, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new way to monitor heart function in patients with end-stage heart failure who have a special heart pump called the HeartMate 3. Currently, the way doctors track the pump's performance and the patient's heart status is limited and not very detailed. This study aims to create a better, non-invasive method to monitor how well the heart is functioning using data from the HeartMate 3 device itself. By comparing this new method with traditional tests like heart ultrasounds and ECGs, the researchers hope to develop a simple and automatic way to keep an eye on patients’ heart health. This could lead to improved treatment and even help some patients recover heart function.

To participate in this trial, patients must be between 18 and 75 years old and have the HeartMate 3 device implanted at the Medical University of Vienna. They need to be able to understand and sign a consent form. However, patients with certain conditions, like known blood clots or issues with blood clotting, cannot join for safety reasons. Participants in the study can expect to undergo regular assessments that will help doctors better understand their heart function in a way that is more frequent and detailed than current methods.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • All patients with the HeartMate 3 system implanted at the Medical University of Vienna, which are able and willing to understand and sign the informed consent form, and which do not meet any exclusion criteria will be included.
• Exclusion Criteria:
• • Age: \<18 or \>75 years
• • Inability to provide informed consent
• • Patients with known intraventricular or aortic root thrombus formation or known pathology of the coagulatory system. Although an intraventricular thrombus formation is usually removed intraoperatively during the LVAD implantation procedure, the rationale for this exclusion criterion is to avoid suction of such thrombus material during possible speed changes (± 20% from the initial pump speed). Consequently, the exclusion of patients with known pathology of the coagulation system, who thus have a higher risk of developing any kind of thrombus formation, is another safety measure.
• • Inaccessibility for transthoracic ultrasound diagnostics. Firstly, as described in the visit and assessment schedule (Appendix), changes in pump speed are only performed under transthoracic echo guidance. Secondly, as described above, echo parameters are required to correlate with the non-invasive CDAS pump data. Therefore, the inaccessibility of ultrasound diagnostics (e.g. due to poor image quality) is another exclusion criterion.