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NCT01124370 · ClinicalTrials.gov registry record · Phase 2
Chronic Evaluation of Respicardia Therapy
A Phase 2 study, sponsored by Respicardia.
- Completed
- Registry status
- Phase 2
- Development phase
- 57
- Enrollment target
NCT01124370: Completed Phase 2 study, sponsored by Respicardia.
NCT01124370 is a Phase 2 study that has completed, run by Respicardia. The registered enrollment target is 57 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01124370, a Phase 2 study, has completed, sponsored by Respicardia.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 57 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the chronic safety and efficacy of phrenic nerve stimulation on central sleep apnea (CSA). Clinically, CSA events translate into sleep fragmentation, excessive daytime sleepiness, reduced exercise capacity, and possibly ventricular arrhythmias. The study is chronic in nature, such that subjects will undergo the implantation of an implantable pulse generator and stimulation lead. A sensing lead may also be placed during the initial implant procedure. Subjects will be followed for up to six-months on therapy to assess respiratory and heart failure outcomes. Following the six-month therapy visit, subjects will enter into a long-term follow-up phase until the completion of the study. It is anticipated that data obtained in this study will show that the proposed intervention can modify respiration with a low incidence of adverse effects. The results of this trial are intended to be used to develop a subsequent protocol for pivotal study.
Primary Outcome
Change = Month 3 score - Baseline score The Apnea-Hypopnea Index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep.
Interventions
- DEVICE remedē (TM) system
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2010-05 |
| Est. Completion | 2014-08 |
| Phase | Phase 2 |
What the finished NCT01124370 record still lists
NCT01124370 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 1 intervention - of which remedē (TM) system is the first listed.
NCT01124370 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01124370 about?
NCT01124370 is a clinical study titled "Chronic Evaluation of Respicardia Therapy". The purpose of this study is to determine the chronic safety and efficacy of phrenic nerve stimulation on central sleep apnea (CSA). Clinically, CSA events translate into sleep fragmentation, excessive daytime sleepiness, reduced exercise capacity, and possibly ventricular arrhythmias. The study is...
What is the current status of trial NCT01124370?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 57 participants. The study started on 2010-05. Estimated completion is 2014-08.
What interventions are being tested in trial NCT01124370?
The interventions under investigation include: remedē (TM) system (DEVICE).
Who is sponsoring clinical trial NCT01124370?
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 NCT01124370's enrollment target sits among peer trials
57 1141st of 2000 higher than 855 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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