RecruitingNCT04641416

Noninvasive Cardiovascular Diagnosis of Patients With Fully Magnetically Levitated Blood Pumps

Pilot Study: Noninvasive Cardiovascular Diagnosis of Patients With Fully Magnetically Levitated Blood Pumps


Sponsor

Thomas Schlöglhofer

Enrollment

60 participants

Start Date

Jul 9, 2020

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is developing new non-invasive methods to monitor the heart health of patients who have had a HeartMate 3 device implanted — a magnetically levitated heart pump (LVAD) used in people with severe heart failure as a bridge to transplant or long-term support. The goal is to detect complications earlier without needing invasive tests. **You may be eligible if...** - You have had a HeartMate 3 LVAD implanted at the Medical University of Vienna - You are able and willing to give informed consent - You are between 18 and 75 years old **You may NOT be eligible if...** - You have a known blood clot inside the heart or in the aorta - You have a condition that increases your risk of forming blood clots - Your chest anatomy makes it impossible to get a clear ultrasound image of the heart Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTRoutinely 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.


Locations(1)

Medical University of Vienna

Vienna, Austria

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NCT04641416


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