Heart Failure Clinical Trial
Official title:
Nicht-invasive Diagnostik in Patienten Mit Herzunterstützungssystemen
NCT number | NCT01981642 |
Other study ID # | MUW_EK-243/2011 |
Secondary ID | KLI357 |
Status | Active, not recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | December 2011 |
Verified date | October 2023 |
Source | Medical University of Vienna |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
- 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.
Status | Active, not recruiting |
Enrollment | 100 |
Est. completion date | |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Austria | General Hospital / Medical University of Vienna | Vienna |
Lead Sponsor | Collaborator |
---|---|
Medical University of Vienna | Austrian Science Fund (FWF) |
Austria,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. |
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