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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04600791
The ClinicalTrials.gov registry entry for NCT04600791 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 93 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CVRx, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which BATwire Implant Kit is the first listed.
NCT04600791 reports 0 study locations.
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.
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