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NCT01816776 · ClinicalTrials.gov registry record · NA
Respicardia, Inc. Pivotal Trial of the remedē System
A NA study, sponsored by Respicardia.
- Completed
- Registry status
- NA
- Development phase
- 151
- Enrollment target
NCT01816776: Completed NA study, sponsored by Respicardia.
NCT01816776 is a NA study that has completed, run by Respicardia. The registered enrollment target is 151 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01816776, a NA study, has completed, sponsored by Respicardia.
- COMPLETED
- Registry status
- NA
- Development phase
- 151 participants
- Enrollment target
Study Summary
The primary purpose of this prospective, multicenter, randomized trial is to evaluate the safety and effectiveness of therapy delivered by the remedē® system in subjects with moderate to severe central sleep apnea and optimal medical management, compared to outcomes in randomized control subjects receiving optimal medical management and implanted but inactive remedē® systems.
Primary Outcome
Comparison of the proportion of subjects in the Treatment group achieving a 50% or greater reduction in AHI from baseline to 6 months compared to the Control group.
Interventions
- DEVICE Treatment Group (transvenous stimulation of the phrenic nerve)
- DEVICE Control Group (Optimal Medical Therapy)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 151 participants |
| Start Date | 2013-03 |
| Est. Completion | 2017-11-07 |
| Phase | NA |
What the finished NCT01816776 record still lists
NCT01816776 is an interventional study that assigns participants to a tested intervention. The registered 151 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 (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Treatment Group (transvenous stimulation of the phrenic nerve) is the first listed.
NCT01816776 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01816776 about?
NCT01816776 is a clinical study titled "Respicardia, Inc. Pivotal Trial of the remedē System". The primary purpose of this prospective, multicenter, randomized trial is to evaluate the safety and effectiveness of therapy delivered by the remedē® system in subjects with moderate to severe central sleep apnea and optimal medical management, compared to outcomes in randomized control subjects re...
What is the current status of trial NCT01816776?
This trial is currently completed. It is a NA study. The enrollment target is 151 participants. The study started on 2013-03. Estimated completion is 2017-11-07.
What interventions are being tested in trial NCT01816776?
The interventions under investigation include: Treatment Group (transvenous stimulation of the phrenic nerve) (DEVICE), Control Group (Optimal Medical Therapy) (DEVICE).
Who is sponsoring clinical trial NCT01816776?
This trial is sponsored by Respicardia, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01816776's enrollment target sits among peer trials
151 661st of 2000 higher than 1,340 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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