NCT04641416 Noninvasive Cardiovascular Diagnosis of Patients With Fully Magnetically Levitated Blood Pumps
| NCT ID | NCT04641416 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Thomas Schlöglhofer, PhD, MSc |
| Condition | End-stage Heart Failure |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2020-07-09 |
| Primary Completion | 2026-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2020-07-09 with a primary completion date of 2026-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Thomas Schlöglhofer, MSc
PRINCIPAL INVESTIGATOR
Medical University of Vienna
Frequently Asked Questions
Who can join the NCT04641416 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying End-stage Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04641416 currently recruiting?
Yes, NCT04641416 is actively recruiting participants. Contact the research team at thomas.schloeglhofer@meduniwien.ac.at for enrollment information.
Where is the NCT04641416 trial being conducted?
This trial is being conducted at Vienna, Austria.
Who is sponsoring the NCT04641416 clinical trial?
NCT04641416 is sponsored by Thomas Schlöglhofer, PhD, MSc. The principal investigator is Thomas Schlöglhofer, MSc at Medical University of Vienna. The trial plans to enroll 60 participants.
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