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NCT04199793 · ClinicalTrials.gov registry record · NA
Lavare Cycle in Patients Receiving HeartWare Left Ventricular Assist Device
A NA study, sponsored by Vanderbilt University Medical Center.
- Terminated
- Registry status
- NA
- Development phase
- 9
- Enrollment target
NCT04199793: Clinical Trial NA study, sponsored by Vanderbilt University Medical Center.
NCT04199793 is a NA study that was terminated before completion, run by Vanderbilt University Medical Center. The registered enrollment target is 9 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04199793, a NA study, was terminated before completion, sponsored by Vanderbilt University Medical Center.
- TERMINATED
- Registry status
- NA
- Development phase
- 9 participants
- Enrollment target
Study Summary
Left ventricular assist device (LVAD) patients remain at risk for pump thrombus and thromboembolic events through multiple mechanisms. The HeartWare® Ventricular Assist System (HVAD®, HeartWare Inc., Framingham, MA, USA) includes a novel speed modulation feature called Lavare™ cycle. The Lavare™ Cycle is aimed to promote washing of left ventricle to decrease blood stasis and subsequent risk of thrombus formation, ingestion and/or expulsion. No prior study has prospectively evaluated the impact of Lavare™ cycle on patient outcomes in a randomized fashion. We intend to assess effects of Lavare™ Cycle among patients receiving HVAD LVAD in this randomized controlled pilot project.
Primary Outcome
INTERMACS definitions of cerebrovascular events, pump hemolysis/ thrombosis will be used. Pump malfunction needing device exchange or emergent transplant will also be included in the main composite event
Interventions
- DEVICE Lavare On
- DEVICE Lavare Off
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2020-08-10 |
| Est. Completion | 2021-08-10 |
| Phase | NA |
Why NCT04199793 stopped before completion
NCT04199793 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Lavare On is the first listed.
NCT04199793 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04199793 about?
NCT04199793 is a clinical study titled "Lavare Cycle in Patients Receiving HeartWare Left Ventricular Assist Device". Left ventricular assist device (LVAD) patients remain at risk for pump thrombus and thromboembolic events through multiple mechanisms. The HeartWare® Ventricular Assist System (HVAD®, HeartWare Inc., Framingham, MA, USA) includes a novel speed modulation feature called Lavare™ cycle. The Lavare™ Cyc...
What is the current status of trial NCT04199793?
This trial is currently terminated. It is a NA study. The enrollment target is 9 participants. The study started on 2020-08-10. Estimated completion is 2021-08-10.
What interventions are being tested in trial NCT04199793?
The interventions under investigation include: Lavare On (DEVICE), Lavare Off (DEVICE).
Who is sponsoring clinical trial NCT04199793?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04199793's enrollment target sits among peer trials
9 1975th of 2000 higher than 25 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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