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NCT04600791 · ClinicalTrials.gov registry record · NA
BATwire Implant Kit
A NA study, sponsored by CVRx.
- Terminated
- Registry status
- NA
- Development phase
- 93
- Enrollment target
NCT04600791: Clinical Trial NA study, sponsored by CVRx.
NCT04600791 is a NA study that was terminated before completion, run by CVRx. The registered enrollment target is 93 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04600791, a NA study, was terminated before completion, sponsored by CVRx.
- TERMINATED
- Registry status
- NA
- Development phase
- 93 participants
- Enrollment target
Study Summary
The purpose of this clinical investigation is to develop valid scientific evidence for the safety and effectiveness of the Barostim System delivered by the BATwire Implant Kit (BATwire Kit) in subjects with heart failure. Subjects may be enrolled if they meet the FDA approved PMA indication for use for the Barostim NEO or Barostim NEO2 device: Subjects who remain symptomatic despite treatment with guideline-directed medical therapy, are NYHA Class III or Class II (who had a recent history of Class III), have a left ventricular ejection fraction ≤ 35%, a NT-proBNP \< 1600 pg/ml and excludes patients indicated for Cardiac Resynchronization Therapy (CRT) according to AHA/ACC/ESC guidelines.
Primary Outcome
To demonstrate the safety of implanting the Barostim lead using the BATwire Implant Kit using all serious adverse events that are related to the BATwire lead implantation that occur between implant, or attempted implant, and 30 days post implant.
Interventions
- DEVICE BATwire Implant Kit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2021-01-29 |
| Est. Completion | 2025-02-17 |
| Phase | NA |
Why NCT04600791 stopped before completion
NCT04600791 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which BATwire Implant Kit is the first listed.
NCT04600791 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04600791 about?
NCT04600791 is a clinical study titled "BATwire Implant Kit". The purpose of this clinical investigation is to develop valid scientific evidence for the safety and effectiveness of the Barostim System delivered by the BATwire Implant Kit (BATwire Kit) in subjects with heart failure. Subjects may be enrolled if they meet the FDA approved PMA indication for use ...
What is the current status of trial NCT04600791?
This trial is currently terminated. It is a NA study. The enrollment target is 93 participants. The study started on 2021-01-29. Estimated completion is 2025-02-17.
What interventions are being tested in trial NCT04600791?
The interventions under investigation include: BATwire Implant Kit (DEVICE).
Who is sponsoring clinical trial NCT04600791?
This trial is sponsored by CVRx, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04600791's enrollment target sits among peer trials
93 937th of 2000 higher than 1,064 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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