Noninvasive monitoring of heart function in patients with LVADs
Pilot Study: Noninvasive Cardiovascular Diagnosis of Patients With Fully Magnetically Levitated Blood Pumps
This study is testing new ways to monitor heart function in people with a HeartMate 3 LVAD to see if they can get better information than the usual methods like echocardiograms and ECGs.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 1 site (Vienna) |
| Trial ID | NCT04641416 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop noninvasive diagnostic methods for assessing cardiac function in patients with the HeartMate 3 left ventricular assist device (LVAD). Currently, monitoring is limited to infrequent data entries, which do not provide adequate insights into the patient's cardiac status. The study will compare new monitoring techniques derived from pump data with standard clinical diagnostic procedures like echocardiograms and ECGs. By improving monitoring capabilities, the study seeks to enhance patient outcomes and optimize LVAD support.
Who should consider this trial
Good fit: Ideal candidates are patients implanted with the HeartMate 3 system who are able to provide informed consent.
Not a fit: Patients under 18 or over 75 years old, or those with specific thrombus formations or coagulation issues, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management of patients with LVADs, potentially enhancing their quality of life and clinical outcomes.
How similar studies have performed: While similar approaches have been explored, this study aims to develop novel noninvasive monitoring techniques specifically for LVAD patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Vienna
- Medical University of Vienna — Vienna, Austria (Recruiting)
Study contacts
- Principal investigator: Thomas Schlöglhofer, MSc — Medical University of Vienna
- Study coordinator: Thomas Schlöglhofer, MSc
- Email: thomas.schloeglhofer@meduniwien.ac.at
- Phone: +4314040027280
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.