Noninvasive monitoring of heart function in patients with LVADs

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 develop noninvasive diagnostic methods for assessing cardiac function in patients with the HeartMate 3 left ventricular assist device (LVAD). Currently, monitoring is limited to infrequent data entries, which do not provide adequate insights into the patient's cardiac status. The study will compare new monitoring techniques derived from pump data with standard clinical diagnostic procedures like echocardiograms and ECGs. By improving monitoring capabilities, the study seeks to enhance patient outcomes and optimize LVAD support.

Why it matters

Who can join: the full rules

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.

Where it's running

• Medical University of Vienna
  Vienna, Austria Recruiting

Study contacts

• Principal investigator: Thomas Schlöglhofer, MSc — Medical University of Vienna
• Study coordinator: Thomas Schlöglhofer, MSc
• Email: thomas.schloeglhofer@meduniwien.ac.at
• Phone: +4314040027280

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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.