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NCT04316481 · ClinicalTrials.gov registry record · NA
IDE-ALERTS Continued Access Study
A NA study, sponsored by Angel Medical Systems.
- Terminated
- Registry status
- NA
- Development phase
- 17
- Enrollment target
NCT04316481: Clinical Trial NA study, sponsored by Angel Medical Systems.
NCT04316481 is a NA study that was terminated before completion, run by Angel Medical Systems. The registered enrollment target is 17 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
NCT04316481, a NA study, was terminated before completion, sponsored by Angel Medical Systems.
- TERMINATED
- Registry status
- NA
- Development phase
- 17 participants
- Enrollment target
Study Summary
This Continued Access IDE Study includes a subset of former ALERTS trial (NCT00781118) patients and provides performance data for a refined Guardian implantable medical device (AMSG3-E) with a new battery designed to extend device longevity.
Primary Outcome
Annual rate of SAEs related to the device or procedure
Interventions
- DEVICE AngelMed Guardian System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2020-09-22 |
| Est. Completion | 2022-01-20 |
| Phase | NA |
Why NCT04316481 stopped before completion
NCT04316481 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 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 AngelMed Guardian System is the first listed.
NCT04316481 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04316481 about?
NCT04316481 is a clinical study titled "IDE-ALERTS Continued Access Study". This Continued Access IDE Study includes a subset of former ALERTS trial (NCT00781118) patients and provides performance data for a refined Guardian implantable medical device (AMSG3-E) with a new battery designed to extend device longevity.
What is the current status of trial NCT04316481?
This trial is currently terminated. It is a NA study. The enrollment target is 17 participants. The study started on 2020-09-22. Estimated completion is 2022-01-20.
What interventions are being tested in trial NCT04316481?
The interventions under investigation include: AngelMed Guardian System (DEVICE).
Who is sponsoring clinical trial NCT04316481?
This trial is sponsored by Angel Medical Systems, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04316481's enrollment target sits among peer trials
17 1871st of 2000 higher than 130 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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