Clinical trial
Respicardia, Inc. Pivotal Trial of the remedē System
NCT01816776 · Respicardia, Inc., Industry · Completed
Key facts
| NCT number | NCT01816776 |
|---|---|
| Title | Respicardia, Inc. Pivotal Trial of the remedē System |
| Official title | A Randomized Trial Evaluating the Safety and Effectiveness of the remedē® System in Patients With Central Sleep Apnea |
| Lead sponsor | Respicardia, Inc., Industry |
| Status | Completed |
| Study type | Interventional |
| Conditions | Sleep Apnea, Central, Sleep Disordered Breathing, Heart Failure |
| Intervention type | Device |
| Interventions | Treatment Group (transvenous stimulation of the phrenic nerve), Control Group (Optimal Medical Therapy) |
| Enrollment | 151 |
| Start date | Mar 1, 2013 |
| Primary completion | Sep 10, 2016 |
| Completion | Nov 7, 2017 |
| First posted | Mar 22, 2013 |
| Last update posted | Jun 29, 2018 |
| Countries | Germany, Poland, United States |
At a glance
- 10–99 Study sites
- Yes Results posted
- 1–9 Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: