Cardiomyopathies Clinical Trial
— HM3_SnoopyOfficial title:
Pilot Study: Noninvasive Cardiovascular Diagnosis of Patients With Fully Magnetically Levitated Blood Pumps
Left Ventricular Assist Device (LVAD) therapy has become a well-established treatment option for endstage heart-failure either as a bridge to transplant (BTT) or destination therapy (DT). Monitoring of the pump and with this the cardiac status with the HeartMate 3 (HM3) is currently very limited to infrequent log-files with one data entry every 15 minutes and only limited amount of entries. Due to the low resolution data, the standard HM3 monitoring is not feasible for the evaluation of suction events or in depth analysis of the interaction between LVAD and the remaining native heart function. Aim of this study is to develop noninvasive diagnostics of the cardiac remaining respectively recovering function derived from HeartMate 3 pump data only and compare with standard clinical diagnostic procedures. These procedures include cardiac ultrasound and ECG. After this pilot study, the newly developed methods would allow frequent, simple and automatic monitoring of patients implanted with the HeartMate 3 device. Such continuous assessment of cardiac function would massively help therapy optimization of cardiac protection and, if possible, cardiac recovery.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 30, 2025 |
Est. primary completion date | December 15, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: All patients with the HeartMate 3 system implanted at the Medical University of Vienna, which are able and willing to understand and sign the informed consent form, and which do not meet any exclusion criteria will be included. Exclusion Criteria: - Age: <18 or >75 years - Inability to provide informed consent - Patients with known intraventricular or aortic root thrombus formation or known pathology of the coagulatory system. Although an intraventricular thrombus formation is usually removed intraoperatively during the LVAD implantation procedure, the rationale for this exclusion criterion is to avoid suction of such thrombus material during possible speed changes (± 20% from the initial pump speed). Consequently, the exclusion of patients with known pathology of the coagulation system, who thus have a higher risk of developing any kind of thrombus formation, is another safety measure. - Inaccessibility for transthoracic ultrasound diagnostics. Firstly, as described in the visit and assessment schedule (Appendix), changes in pump speed are only performed under transthoracic echo guidance. Secondly, as described above, echo parameters are required to correlate with the non-invasive CDAS pump data. Therefore, the inaccessibility of ultrasound diagnostics (e.g. due to poor image quality) is another exclusion criterion. |
Country | Name | City | State |
---|---|---|---|
Austria | Medical University of Vienna | Vienna |
Lead Sponsor | Collaborator |
---|---|
Thomas Schlöglhofer | Abbott, German Heart Center |
Austria,
(1.) T. Imamura et al. Optimal Hemodynamics during Left Ventricular Assist Device Support Are Associated with Reduced Readmission Rates. Circ. Hear. Fail., vol. 12, no. 2, pp. 1-11, 2019. (2.) M. Vollkron, et al. Suction Events During Left Ventricular Support and Ventricular Arrhythmias. J. Hear. Lung Transplant., vol. 26, no. 8, pp. 819-825, 2007. (3.) Moscato F, et al. Evaluation of Left Ventricular Relaxation in Rotary Blood Pump Recipients Using the Pump Flow Waveform: A Simulation Study. Artif Organs 2012; 36:470-478 (4.) M. Vollkron, et al. Development of a suction detection system for axial blood pumps. Artif. Organs, vol. 28, no. 8, pp. 709-716, 2004. (5.) Moscato F, et al. Continuous monitoring of cardiac rhythms in left ventricular assist device patients. Artif Organs 2014; 38:191-198 (6.) Gross C, et al. Continuous LVAD monitoring reveals high suction rates in clinically stable outpatients. Artif Organs. 2020 Jan 16. doi: 10.1111/aor.13638. [Epub ahead of print]
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of suction events and suction burden (percentage number of suction operation in relation to normal operation) evaluated using routinely available HeartMate 3 log files and high-resolution CDAS data | The incidence of suction events and suction burden due to hemodynamically changes during follow-up will be evaluated with high resolution continuous data acquisition system (CDAS) data and the routinely available HeartMate 3 logfiles and compared to each other.
Null hypothesis: There is no difference in the incidence of suction events and suction burden assessed by routinely available HeartMate 3 log files and high-resolution CDAS data. |
2 years | |
Secondary | Change of left ventricular unloading during pump speed changes (+- 20% from baseline speed) | Change of left ventricular unloading as assessed by routinely performed hemodynamic monitoring (pulmonary capillary wedge pressure), echocardiography (left ventricular dimensions at end-systole and diastole) and non-invasive CDAS peak-to-peak pump flow. Correlation of left ventricular unloading measures (echo dimensions and pulmonary capillary wedge pressure) with the non-invasive peak-to-peak pump flow under investigation using Spearman and Pearson correlation coefficients (depending of the probability density function of the dataset) and graphical representation of the pair-wise correlations is done by means of a scatter diagram.
Null hypothesis: There is no difference in the change of left ventricular unloading as assessed by pulmonary capillary wedge pressure, left ventricular dimensions at end-systole and diastole, and non-invasively assessed CDAS peak-to-peak pump flow. |
at post operative day 3, hospital discharge and at 6 months following hospital discharge |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05428787 -
Resynchronization in Patients With HF in AF Trial Undergoing Pace & AVNA Strategy With LBBAP Compared With BiV Pacing
|
N/A | |
Not yet recruiting |
NCT05567445 -
Outcome of Cardiomyopathic Adults Admission in ICU.
|
||
Completed |
NCT02555527 -
Contrast Echocardiography Cost Effectiveness for Left Ventricular Thrombus Assessment
|
N/A | |
Completed |
NCT00371891 -
Ontario Multidetector Computed Tomographic (MDCT) Coronary Angiography Study (OMCAS)
|
Phase 4 | |
Recruiting |
NCT05552521 -
Diastolic Dysfunction in Septic Shock and Cardiomyopathy Genetic Variants
|
||
Recruiting |
NCT04166331 -
Adjunctive DobutAmine in sePtic Cardiomyopathy With Tissue Hypoperfusion
|
Phase 3 | |
Terminated |
NCT06331507 -
Refinement and Assessment of New MRI Technologies for Cardiovascular Exams Using the Phillips CMR Patch
|
N/A | |
Completed |
NCT01953523 -
Safety and Clinical Outcomes Study: SVF Deployment for Orthopedic, Neurologic, Urologic, and Cardio-pulmonary Conditions
|
N/A | |
Recruiting |
NCT04695119 -
Sepsis in the ICU-II
|
||
Completed |
NCT03228966 -
Ped HIV - Echo Study: Kenya
|
||
Not yet recruiting |
NCT06348732 -
Diagnostic and Prognostic Role of Troponin and Brain Natriuretic Peptide in Pediatric Patients With Cardiomyopathy in Correlation to Echocardiography Findings
|
||
Recruiting |
NCT05556369 -
Genetic Characterization of Cardiomyopathies (POLICARDIOMIO2021)
|
||
Recruiting |
NCT04520646 -
A Pilot Study of Empagliflozin in the Treatment of Acromegalic Cardiomyopathy
|
N/A | |
Not yet recruiting |
NCT03899298 -
Safety and Clinical Outcomes With Amniotic and Umbilical Cord Tissue Therapy for Numerous Medical Conditions
|
Phase 1 | |
Completed |
NCT04323852 -
Can Vitamin D Reduce Heart Muscle Damage After Bypass Surgery?
|
Phase 4 | |
Completed |
NCT03527381 -
Nitric Oxide in Cardiopulmonary Bypass for Renal Protection in Cardiac Surgery
|
Phase 1/Phase 2 | |
Withdrawn |
NCT02462213 -
Prospective Identification of Cardiac Amyloidosis by Cardiac Magnetic Resonance Imaging
|
N/A | |
Active, not recruiting |
NCT00418041 -
Chronic Heart Failure Analysis and Registry in the Tohoku District 2 (CHART-2 Study)
|
N/A | |
Not yet recruiting |
NCT06091475 -
Therapy to Maintain Remission in Dilated Cardiomyopathy
|
N/A | |
Recruiting |
NCT03317964 -
Genetic Basis of Pacing-induced Cardiomyopathy
|