N/A
Completed N=53
Post Approval Study of the remedē System
Central Sleep Apnea
Source: ClinicalTrials.gov NCT03425188 ↗
Enrolled (actual)
53
Serious AEs
43.4%
Results posted
Apr 2021
Primary outcomePrimary: 5-Year Survival Rate — 78 percentage of participants
Summary
Prospective, single arm cohort study to evaluate the long-term safety, long-term effectiveness, and survival rate in subjects implanted with the remedē System.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 5-Year Survival Rate |
78 | — |
| PRIMARY Number of Participants With Device-related Serious Adverse Events (SAEs) Through Three and Five Years |
9; 12 | — |
| PRIMARY Number of Participants With Therapy-related Serious Adverse Events (SAEs) Through Three and Five Years |
4; 4 | — |
| PRIMARY Apnea-Hypopnea Index (AHI) Change From Baseline at 5 Years |
-22 | — |
| PRIMARY Epworth Sleepiness Scale (ESS) Change From Baseline at 5 Years |
-3 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who were previously implanted with the remedē System and participated in the remedē System Pivotal Trial
- In the investigator's opinion, willing and able to comply with all study requirements
- Signed Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent (including Health Insurance Portability and Accountability Act [HIPAA] authorization in the US)
Exclusion Criteria
- There are no criteria by which a subject would be excluded
Data sourced from ClinicalTrials.gov (NCT03425188). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.