Noninvasive Diagnostics in Left Ventricular Assist Device Patients

NCT ID: NCT01981642

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31

Brief 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). 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.

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.

Conditions

Heart Failure; Artificial Heart Device User

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients with a LVAD implanted.

Recording of LVAD data during routine visits and daily life. Recording of daily activity using wristwatch accelerometers.

Group Type: EXPERIMENTAL

Recording of LVAD data during routine visits and daily life.

Intervention Type: OTHER

Noninvasive diagnostic intervention.

Recording of daily activity using wristwatch accelerometers.

Intervention Type: OTHER

Noninvasive diagnostic intervention.

Interventions

Recording of LVAD data during routine visits and daily life.

Noninvasive diagnostic intervention.

Intervention Type: OTHER

Recording of daily activity using wristwatch accelerometers.

Noninvasive diagnostic intervention.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Austrian Science Fund (FWF)

OTHER

Sponsor Role: collaborator

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Francesco Moscato

Assoc. Prof. Dipl.-Ing. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francesco Moscato, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Daniel Zimpfer, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Heinrich Schima, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

General Hospital / Medical University of Vienna

Vienna, , Austria

Countries

Austria

References

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.

Reference Type: BACKGROUND

PMID: 24102321 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23902542 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22882439 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22171892 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19782591 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16934094 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39231213 (View on PubMed)

Other Identifiers

KLI357

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

MUW_EK-243/2011

Identifier Type: -

Identifier Source: org_study_id