Noninvasive Cardiovascular Diagnosis of Patients With Fully Magnetically Levitated Blood Pumps

NCT04641416 | Recruiting

• 1 other identifier: EK Nr: 1251/2020
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

End-stage Heart Failure; Cardiomyopathies; Mechanical Circulatory Support

Keywords

ventricular assist device; non-invasive monitoring

Outcome Measures

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.

  2 years

Secondary Outcomes (1)

• Change of left ventricular unloading during pump speed changes (+- 20% from baseline speed)

  at post operative day 3, hospital discharge and at 6 months following hospital discharge

Study Arms (1)

Noninvasive pump monitoring

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.

Diagnostic Test: Routinely performed echo, ECG and hemodynamic monitoring

Interventions

Routinely performed echo, ECG and hemodynamic monitoring DIAGNOSTIC_TEST

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.

Noninvasive pump monitoring

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may not qualify if:

• Age: \<18 or \>75 years
• Inability to provide informed consent

Sponsors & Collaborators

• Thomas Schlöglhofer: lead
• Abbott: collaborator
• German Heart Center: collaborator

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

Related Publications (1)

• (1.) T. Imamura et al. Optimal Hemodynamics during Left Ventricular Assist Device Support Are Associated with Reduced Readmission Rates. Circ. Hear. Fail., vol. 12, no. 2, pp. 1-11, 2019. (2.) M. Vollkron, et al. Suction Events During Left Ventricular Support and Ventricular Arrhythmias. J. Hear. Lung Transplant., vol. 26, no. 8, pp. 819-825, 2007. (3.) Moscato F, et al. Evaluation of Left Ventricular Relaxation in Rotary Blood Pump Recipients Using the Pump Flow Waveform: A Simulation Study. Artif Organs 2012; 36:470-478 (4.) M. Vollkron, et al. Development of a suction detection system for axial blood pumps. Artif. Organs, vol. 28, no. 8, pp. 709-716, 2004. (5.) Moscato F, et al. Continuous monitoring of cardiac rhythms in left ventricular assist device patients. Artif Organs 2014; 38:191-198 (6.) Gross C, et al. Continuous LVAD monitoring reveals high suction rates in clinically stable outpatients. Artif Organs. 2020 Jan 16. doi: 10.1111/aor.13638. [Epub ahead of print]

  BACKGROUND

MeSH Terms

Conditions

Cardiomyopathies

Interventions

Electrocardiography; Hemodynamic Monitoring

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Monitoring, Physiologic

Study Officials

• Thomas Schlöglhofer, MSc

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Schlöglhofer, MSc

CONTACT

+4314040027280; thomas.schloeglhofer@meduniwien.ac.at

Daniel Zimpfer, MD

CONTACT

+4314040052620; daniel.zimpfer@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: November 23, 2020
• Study Start: July 9, 2020
• Primary Completion: December 15, 2025
• Study Completion: December 30, 2025
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)