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Heart FailureNCT01981642

Noninvasive Diagnostics in Left Ventricular Assist Device Patients

A study testing Recording of LVAD data during routine visits and daily life. and Recording of daily activity using wristwatch accelerometers. in people with Heart Failure and Artificial Heart Device User, run by Medical University of Vienna at 1 site in Austria.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Heart Failure, Artificial Heart Device User
What is being tested?
Recording of LVAD data during routine visits and daily life. and Recording of daily activity using wristwatch accelerometers.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteAustria
Study dates
Dec 2011to Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • General Hospital / Medical University of Vienna

    Vienna, 1090

Other trials in Austria

About this study

Official title: 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.
Read the 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.
Being tested
Recording of LVAD data during routine visits and daily life., Recording of daily activity using wristwatch accelerometers.
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Recording of LVAD data during routine visits and daily life.Other

    Noninvasive diagnostic intervention.

  • Recording of daily activity using wristwatch accelerometers.Other

    Noninvasive diagnostic intervention.

Study groups in NCT01981642
Study groupRoleWhat they receive
Patients with a LVAD implanted.ExperimentalRecording of LVAD data during routine visits and daily life. Recording of daily activity using wristwatch accelerometers.
Receives: Other: Recording of LVAD data during routine visits and daily life.; Other: Recording of daily activity using wristwatch accelerometers.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sensitivity/specificity of LVAD-based methods to monitor the cardiovascular function when compared to routine clinical diagnostics.

    Measured: Participants will be followed for the duration of LVAD implant, an expected average of 2 years.

Secondary outcomes (1)

  1. Documentation of daily life activities as measured using wristwatch accelerometers and routine clinical exercise tests.

    Measured: Participants will be followed for the duration of LVAD implant, an expected average of 2 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Nov 2013 (estimated)
  2. Study startDec 2011
  3. Primary completionDec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01981642
Sponsor's protocol ID
MUW_EK-243/2011
Other IDs
KLI357
Status last verified
Oct 2023
First submitted
29 Oct 2013
Last updated
23 Oct 2023
Results posted
No
Data monitoring committee
No

Publications

  • Granegger M, Schima H, Zimpfer D, Moscato F. Assessment of aortic valve opening during rotary blood pump support using pump signals. Artif Organs. 2014 Apr;38(4):290-7. doi: 10.1111/aor.12167. Epub 2013 Sep 19.

    PubMed 24102321

  • Moscato F, Granegger M, Edelmayer M, Zimpfer D, Schima H. Continuous monitoring of cardiac rhythms in left ventricular assist device patients. Artif Organs. 2014 Mar;38(3):191-8. doi: 10.1111/aor.12141. Epub 2013 Aug 1.

    PubMed 23902542

  • Granegger M, Moscato F, Casas F, Wieselthaler G, Schima H. Development of a pump flow estimator for rotary blood pumps to enhance monitoring of ventricular function. Artif Organs. 2012 Aug;36(8):691-9. doi: 10.1111/j.1525-1594.2012.01503.x.

    PubMed 22882439

  • Moscato F, Granegger M, Naiyanetr P, Wieselthaler G, Schima H. Evaluation of left ventricular relaxation in rotary blood pump recipients using the pump flow waveform: a simulation study. Artif Organs. 2012 May;36(5):470-8. doi: 10.1111/j.1525-1594.2011.01392.x. Epub 2011 Dec 16.

    PubMed 22171892

  • Naiyanetr P, Moscato F, Vollkron M, Zimpfer D, Wieselthaler G, Schima H. Continuous assessment of cardiac function during rotary blood pump support: a contractility index derived from pump flow. J Heart Lung Transplant. 2010 Jan;29(1):37-44. doi: 10.1016/j.healun.2009.05.032. Epub 2009 Sep 26.

    PubMed 19782591

  • Vollkron M, Schima H, Huber L, Benkowski R, Morello G, Wieselthaler G. Advanced suction detection for an axial flow pump. Artif Organs. 2006 Sep;30(9):665-70. doi: 10.1111/j.1525-1594.2006.00282.x.

    PubMed 16934094

  • Berger L, Haberbusch M, Gross C, Moscato F. Enhancing Heart Failure Care: Deep Learning-Based Activity Classification in Left Ventricular Assist Device Patients. ASAIO J. 2025 Jan 1;71(1):52-60. doi: 10.1097/MAT.0000000000002299. Epub 2024 Sep 4.

    PubMed 39231213

Questions about this trial

What is this clinical trial studying?

A study testing Recording of LVAD data during routine visits and daily life. and Recording of daily activity using wristwatch accelerometers. in people with Heart Failure and Artificial Heart Device User, run by Medical University of Vienna at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01981642, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023; AzTrials last refreshed its copy on 1 Nov 2026.

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