NCT04641416Recruiting
Noninvasive Cardiovascular Diagnosis of Patients With Fully Magnetically Levitated Blood Pumps
Pilot Study: Noninvasive Cardiovascular Diagnosis of Patients With Fully Magnetically Levitated Blood Pumps
Source: ClinicalTrials.gov · Last updated 8 May 2026
Brief summary (registry, in English)
Left Ventricular Assist Device (LVAD) therapy has become a well-established treatment option for endstage heart-failure either as a bridge to transplant (BTT) or destination therapy (DT). Monitoring of the pump and with this the cardiac status with the HeartMate 3 (HM3) is currently very limited to infrequent log-files with one data entry every 15 minutes and only limited amount of entries. Due to the low resolution data, the standard HM3 monitoring is not feasible for the evaluation of suction events or in depth analysis of the interaction between LVAD and the remaining native heart function. Aim of this study is to develop noninvasive diagnostics of the cardiac remaining respectively recovering function derived from HeartMate 3 pump data only and compare with standard clinical diagnostic procedures. These procedures include cardiac ultrasound and ECG. After this pilot study, the newly developed methods would allow frequent, simple and automatic monitoring of patients implanted with the HeartMate 3 device. Such continuous assessment of cardiac function would massively help therapy optimization of cardiac protection and, if possible, cardiac recovery.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 28 Jul 2020
- Start date
- 9 Jul 2020
- Primary completion date
- 15 Dec 2026
- Lead sponsor
- Thomas Schlöglhofer, PhD, MSc
- Diseases
- Heart failure
- NCT number
- NCT04641416
What you commit to
- Study type: Observational
- Planned participants: 60
- From 9 Jul 2020 to the primary completion date, 15 Dec 2026
- 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.
Age
- Age: \<18 or \>75 years
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · 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 |
|---|---|---|---|
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.