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Noninvasive Cardiovascular Diagnosis of Patients With Fully Magnetically Levitated Blood Pumps

NCT04641416 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2026-05-08

No results posted yet for this study

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.

Conditions

  • End-stage Heart Failure
  • Cardiomyopathies
  • Mechanical Circulatory Support

Interventions

DIAGNOSTIC_TEST

Routinely performed echo, ECG and hemodynamic monitoring

The 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.

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • German Heart Center

    collaborator OTHER

  • Thomas Schlöglhofer, PhD, MSc

    lead OTHER

Principal Investigators

  • Thomas Schlöglhofer, MSc · Medical University of Vienna

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-09
Primary Completion
2026-12-15
Completion
2026-12-30

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04641416 on ClinicalTrials.gov