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NCT03425422 · ClinicalTrials.gov registry record · NA
ANTHEM-HFrEF Pivotal Study
A NA study, sponsored by LivaNova.
- Terminated
- Registry status
- NA
- Development phase
- 533
- Enrollment target
NCT03425422: Clinical Trial NA study, sponsored by LivaNova.
NCT03425422 is a NA study that was terminated before completion, run by LivaNova. The registered enrollment target is 533 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03425422, a NA study, was terminated before completion, sponsored by LivaNova.
- TERMINATED
- Registry status
- NA
- Development phase
- 533 participants
- Enrollment target
Study Summary
A multi-center randomized controlled clinical trial to evaluate Autonomic Regulation Therapy with the VITARIA system in patients with symptomatic heart failure and reduced ejection fraction.
Primary Outcome
The event-free rate, through 90 days after VITARIA implantation, from all VITARIA system-related and VITARIA implantation-related serious adverse events, as adjudicated by the Clinical Events Committee
Interventions
- DEVICE VITARIA System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 533 participants |
| Start Date | 2018-05-01 |
| Est. Completion | 2023-05-31 |
| Phase | NA |
Why NCT03425422 stopped before completion
NCT03425422 is an interventional study that assigns participants to a tested intervention. The registered 533 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 1 intervention - of which VITARIA System is the first listed.
NCT03425422 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03425422 about?
NCT03425422 is a clinical study titled "ANTHEM-HFrEF Pivotal Study". A multi-center randomized controlled clinical trial to evaluate Autonomic Regulation Therapy with the VITARIA system in patients with symptomatic heart failure and reduced ejection fraction.
What is the current status of trial NCT03425422?
This trial is currently terminated. It is a NA study. The enrollment target is 533 participants. The study started on 2018-05-01. Estimated completion is 2023-05-31.
What interventions are being tested in trial NCT03425422?
The interventions under investigation include: VITARIA System (DEVICE).
Who is sponsoring clinical trial NCT03425422?
This trial is sponsored by LivaNova, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03425422's enrollment target sits among peer trials
533 188th of 2000 higher than 1,813 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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