Noninvasive Cardiovascular Diagnosis of Patients With Fully Magnetically Levitated Blood Pumps
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorThomas Schlöglhofer, PhD, MSc
About this trial
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
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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.
Trial population
End-stage heartfailure patients (NYHA IV), receiving a HeartMate 3 LVAD at the Medical University of Vienna either as bridge to transplant or destination therapy.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Routinely performed echo, ECG and hemodynamic monitoring
Diagnostic testThe pump data of patients on the ICU or normal ward are stored in a continuous data acquisition system (CDAS) on a notebook which is operated in battery operation, and analyzed afterwards with a mat-lab based software. For outpatients a mobile data-recorder will allow a continuous data acquisition for a period up to 2 months on a SD card. During this non-invasive pump data monitoring, routinely available hemodynamic monitoring, ECG and echo data will be collected.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Noninvasive pump monitoring1 intervention
Trial outcomes
Primary outcomes
1
Incidence of suction events and suction burden (percentage number of suction operation in relation to normal operation) evaluated using routinely available HeartMate 3 log files and high-resolution CDAS data
The incidence of suction events and suction burden due to hemodynamically changes during follow-up will be evaluated with high resolution continuous data acquisition system (CDAS) data and the routinely available HeartMate 3 logfiles and compared to each other. Null hypothesis: There is no difference in the incidence of suction events and suction burden assessed by routinely available HeartMate 3 log files and high-resolution CDAS data.
Time frame
2 yearsSecondary outcomes
1
Change of left ventricular unloading during pump speed changes (+- 20% from baseline speed)
Change of left ventricular unloading as assessed by routinely performed hemodynamic monitoring (pulmonary capillary wedge pressure), echocardiography (left ventricular dimensions at end-systole and diastole) and non-invasive CDAS peak-to-peak pump flow. Correlation of left ventricular unloading measures (echo dimensions and pulmonary capillary wedge pressure) with the non-invasive peak-to-peak pump flow under investigation using Spearman and Pearson correlation coefficients (depending of the probability density function of the dataset) and graphical representation of the pair-wise correlations is done by means of a scatter diagram. Null hypothesis: There is no difference in the change of left ventricular unloading as assessed by pulmonary capillary wedge pressure, left ventricular dimensions at end-systole and diastole, and non-invasively assessed CDAS peak-to-peak pump flow.
Time frame
at post operative day 3, hospital discharge and at 6 months following hospital dischargeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Thomas Schlöglhofer, PhD, MSc
Lead sponsor
Medical University of Vienna
Sponsor institution
Abbott
Collaborator
German Heart Center
Collaborator
Source ClinicalTrials.gov