Noninvasive Diagnostics in Left Ventricular Assist Device Patients

NCT01981642 | Unknown

• 2 other identifiers: MUW_EK-243/2011KLI357
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Artificial Heart Device User

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (1)

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

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

Study Arms (1)

Patients with a LVAD implanted.

EXPERIMENTAL

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.; Other: Recording of daily activity using wristwatch accelerometers.

Interventions

Recording of LVAD data during routine visits and daily life. OTHER

Noninvasive diagnostic intervention.

Patients with a LVAD implanted.

Recording of daily activity using wristwatch accelerometers. OTHER

Noninvasive diagnostic intervention.

Patients with a LVAD implanted.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Vienna: lead
• Austrian Science Fund (FWF): collaborator

Study Sites (1)

General Hospital / Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (7)

• 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.

  PMID: 24102321 BACKGROUND

• 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.

  PMID: 23902542 BACKGROUND

• 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.

  PMID: 22882439 BACKGROUND

• 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.

  PMID: 22171892 BACKGROUND

• 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.

  PMID: 19782591 BACKGROUND

• 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.

  PMID: 16934094 BACKGROUND

• 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.

  PMID: 39231213 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dipl.-Ing. Dr.

Study Record Dates

• First Submitted: October 29, 2013
• First Posted: November 11, 2013
• Study Start: December 1, 2011
• Primary Completion: December 1, 2024
• Last Updated: October 23, 2023

Record last verified: 2023-10

Locations

AU (1)