Noninvasive Diagnostics in Left Ventricular Assist Device Patients

October 20, 2023 updated by: Francesco Moscato, Medical University of Vienna

Nicht-invasive Diagnostik in Patienten Mit Herzunterstützungssystemen

  • Study Purpose: The purpose of this study is to evaluate the sensitivity/specificity of noninvasive diagnostic methods for the cardiac function that are based on data available from the Left Ventricular Assist Device (LVAD). These diagnostic methods will be compared to standard clinical diagnostic procedures both at rest and during exercise.
  • Study Design: The study is a prospective interventional cohort study.
  • Patient cohort: Thirty heart failure patients who had or are about to have a LVAD implanted.
  • Data Collection: The acquisition of LVAD data (motor current and speed) and wristwatch accelerometry data concurrently to the documentation of routine clinical examinations, such as cardiac ultrasound, electrocardiography (ECG), cardiac catheterization, and exercise tests, will be performed.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

  • Background: In recent years Left Ventricular Assist Devices (LVADs) have become the devices of choice to treat patients with advanced heart failure. Proper evaluation of the cardiovascular function under LVAD support is of key importance especially for the preservation of the assisted cardiac function or for the evaluation of an eventual cardiac recovery. Cardiac echocardiography, electrocardiography and catheterization, as well as exercise testing are the standard clinical methods for the evaluation of the cardiovascular function during LVAD support. All these methods require however time-consuming procedures, and are therefore unacceptably cumbersome for frequent monitoring. On the other hand, a frequent and effective noninvasive evaluation of the cardiac status provided by the LVAD itself would have a remarkable impact on LVAD patients and their therapy. Previously developed methods to assess the cardiovascular status from data available from the LVAD (see references given) will be now investigated in a prospective clinical study.
  • Purpose: The main purpose of this study is evaluate the sensitivity/specificity of LVAD based diagnostics when compared to standard clinical diagnostic procedures both at rest and during exercise. Secondarily, the physical activity of patients will be evaluated following LVAD implantation.
  • Methods: Seventy-five heart failure patients who had or are about to have a LVAD implanted will be enrolled in this study. In these patients, the LVAD data (motor current and speed) will be recorded concurrently to the routine clinical examinations and during daily life. The routine clinical examinations typically consist of a subset of the following procedures: cardiac ultrasound, cardiac catheterization, 24h ECG measurement, exercise tests (6-minute walk test and spiroergometry). Parameters from the LVAD data that reflect contractile and relaxation properties as well as and aortic valve opening will be compared to echocardiography. Parameters from the LVAD data that reflect cardiac rhythms will be compared to ECG measurements. Both cardiac hemodynamics and rhythms during exercise tests will be assessed using the developed methods based on LVAD data. Finally, wristwatch accelerometers will be used for a quantification and evaluation of patient daily life activity. This measurements will be compared to 6-minute walk test and spiroergometry data as well as with the diagnostics methods based on the LVAD data.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • General Hospital / Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Signed informed consent obtained from the subject prior to participation;
  • At least 18 years of age and maximum 70 years old;
  • Subjects who received or are about to receive an LVAD.

Exclusion Criteria:

  • Coagulation system disorders;
  • Pregnant or breast-feeding women;
  • Patients with bi-ventricular assist devices.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with a LVAD implanted.
Recording of LVAD data during routine visits and daily life. Recording of daily activity using wristwatch accelerometers.
Other: Recording of LVAD data during routine visits and daily life.
Noninvasive diagnostic intervention.
Other: Recording of daily activity using wristwatch accelerometers.
Noninvasive diagnostic intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensitivity/specificity of LVAD-based methods to monitor the cardiovascular function when compared to routine clinical diagnostics.
Time Frame: Participants will be followed for the duration of LVAD implant, an expected average of 2 years.
Participants will be followed for the duration of LVAD implant, an expected average of 2 years.

Secondary Outcome Measures

Outcome Measure
Time Frame
Documentation of daily life activities as measured using wristwatch accelerometers and routine clinical exercise tests.
Time Frame: Participants will be followed for the duration of LVAD implant, an expected average of 2 years.
Participants will be followed for the duration of LVAD implant, an expected average of 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Collaborators

Austrian Science Fund (FWF)

Investigators

  • Principal Investigator: Francesco Moscato, PhD, Medical University of Vienna
  • Principal Investigator: Daniel Zimpfer, MD, Medical University of Vienna
  • Principal Investigator: Heinrich Schima, PhD, Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

October 29, 2013

First Submitted That Met QC Criteria

November 5, 2013

First Posted (Estimated)

November 11, 2013

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 20, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUW_EK-243/2011
  • KLI357 (Other Grant/Funding Number: Austrian Science Fund (FWF))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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