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NCT04227977 · ClinicalTrials.gov registry record · NA
Volume Optimization Incorporating Negative Pressure Diuresis in Heart Failure (VOID-HF)
A NA study, sponsored by 3ive Labs.
- Completed
- Registry status
- NA
- Development phase
- 8
- Enrollment target
NCT04227977: Completed NA study, sponsored by 3ive Labs.
NCT04227977 is a NA study that has completed, run by 3ive Labs. The registered enrollment target is 8 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
NCT04227977, a NA study, has completed, sponsored by 3ive Labs.
- COMPLETED
- Registry status
- NA
- Development phase
- 8 participants
- Enrollment target
Study Summary
The Cardiorenal Syndrome during Acute decompensated heart failure (ADHF) with persistent congestion despite high dose IV diuretic therapy is associated with remarkable morbidity, which can include the need for renal dialysis or ultrafiltration, an increased length of stay, and high mortality rates. The aims and purpose of this feasibility clinical research trial are: 1. to evaluate the safety profiles associated with performing negative pressure diuresis for the treatment of hypervolemia associated with the cardiorenal syndrome during ADHF with persistent congestion despite high dose IV diuretic therapy via the investigational JuxtaFlow® System, and 2. to evaluate the effectiveness of the investigational JuxtaFlow System in treatment of hypervolemia associated with ADHF.
Primary Outcome
The characterization of the type, frequency, severity, and device-relatedness of adverse events (AEs) associated with the placement, use, and removal of the JuxtaFlow System and a 28-day post-treatment follow up.
Interventions
- DEVICE JuxtaFlow System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2020-06-12 |
| Est. Completion | 2023-10-20 |
| Phase | NA |
What the finished NCT04227977 record still lists
NCT04227977 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 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 1 intervention - of which JuxtaFlow System is the first listed.
NCT04227977 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04227977 about?
NCT04227977 is a clinical study titled "Volume Optimization Incorporating Negative Pressure Diuresis in Heart Failure (VOID-HF)". The Cardiorenal Syndrome during Acute decompensated heart failure (ADHF) with persistent congestion despite high dose IV diuretic therapy is associated with remarkable morbidity, which can include the need for renal dialysis or ultrafiltration, an increased length of stay, and high mortality rates. ...
What is the current status of trial NCT04227977?
This trial is currently completed. It is a NA study. The enrollment target is 8 participants. The study started on 2020-06-12. Estimated completion is 2023-10-20.
What interventions are being tested in trial NCT04227977?
The interventions under investigation include: JuxtaFlow System (DEVICE).
Who is sponsoring clinical trial NCT04227977?
This trial is sponsored by 3ive Labs, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04227977's enrollment target sits among peer trials
8 1976th of 2000 higher than 19 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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