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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 is a Phase 2 study that has completed, run by Respicardia. The registered enrollment target is 57 participants.
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.
Interventions
- DEVICE remedē (TM) system
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2010-05 |
| Est. Completion | 2014-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01124370
The ClinicalTrials.gov registry entry for NCT01124370 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Respicardia, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which remedē (TM) system is the first listed.
NCT01124370 reports 0 study locations.
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.
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