Post Approval Study of the remedē System

Study Overview
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Brief Summary
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Prospective, single arm cohort study to evaluate the long-term safety, long-term effectiveness, and survival rate in subjects implanted with the remedē System.

Detailed Description
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This Post Approval Study is a multi-center, prospective, single arm cohort study to evaluate the long-term safety, long-term effectiveness, and survival rate in subjects implanted with the remedē System from the remedē System Pivotal Trial. Only subjects who were implanted and actively being followed as part of the remedē System Pivotal Trial are eligible. An individual subject's participation is expected to continue to five years post remedē System implant.

Official Title
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Post Approval Study of the remedē System

Conditions
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Central Sleep Apnea

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| remedē System Subjects<br>Subjects who were implanted with the remedē System and actively followed as part of the remedē System Pivotal Trial at the time of study closure. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-Year Survival Rate | Assessment of survival in subjects with moderate to severe central sleep apnea being treated with the remedē System. The 5-year survival rate was estimated from Kaplan-Meier anlaysis, using time from implant to death, study exit or last contact. This analysis used all subjects enrolled in the original remede System Pivotal Trial. | Through 5 years | 
| Number of Participants With Device-related Serious Adverse Events (SAEs) Through Three and Five Years | Assessment of long-term safety via a summary of anticipated or unanticipated device-related SAEs. Proportion of subjects experiencing a device related SAE through the time point of interest. This analysis combined data from the original pivotal trial and this post approval study. | Through 5 years | 
| Number of Participants With Therapy-related Serious Adverse Events (SAEs) Through Three and Five Years | Assessment of the safety of the remedē System by evaluating anticipated or unanticipated therapy-related SAEs. Proportion of subjects experiencing a therapy related SAE through the time point of interest. | Through 3 and 5 years | 
| Apnea-Hypopnea Index (AHI) Change From Baseline at 5 Years | Change in AHI = Year 5 index - Baseline index. The Apnea-Hypopnea Index is a measurement obtained from an overnight sleep study used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. The events were scored according to the 2007 American Academy of Sleep Medicine manual for the scoring of sleep and associated events: rules, terminology and technical specifications (Iber, et. al). | 5 years | 
| Epworth Sleepiness Scale (ESS) Change From Baseline at 5 Years | Change in ESS = Year 5 score - Baseline score. The ESS is an assessment to measure a subject's general level of daytime sleepiness. Scores can range from 0-24, with higher scores indicating higher level of daytime sleepiness. | 5 years |