Actively Recruiting

Age: 18Years - 75Years
All Genders
NCT04641416

Noninvasive Cardiovascular Diagnosis of Patients With Fully Magnetically Levitated Blood Pumps

Led by Thomas Schlöglhofer, PhD, MSc · Updated on 2026-05-08

60

Participants Needed

1

Research Sites

337 weeks

Total Duration

On this page

Sponsors

T

Thomas Schlöglhofer, PhD, MSc

Lead Sponsor

A

Abbott

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Noninvasive Cardiovascular Diagnosis of Patients With Fully Magnetically Levitated Blood Pumps

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with the HeartMate 3 system implanted at the Medical University of Vienna
  • Able and willing to understand and sign the informed consent form
  • Do not meet any exclusion criteria
Not Eligible

You will not qualify if you...

  • Age younger than 18 or older than 75 years
  • Unable to provide informed consent
  • Known intraventricular or aortic root thrombus formation
  • Known pathology of the coagulation system
  • Inability to undergo transthoracic ultrasound diagnostics due to poor image quality or inaccessibility

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Medical University of Vienna

Vienna, Austria, 1090

Actively Recruiting

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Research Team

T

Thomas Schlöglhofer, MSc

CONTACT

D

Daniel Zimpfer, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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