remedē System Therapy Study

Study Overview
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Brief Summary
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The purpose of this non-randomized post market study is to collect clinical data on the safety and effectiveness of the remedē System in a real-world setting.

Detailed Description
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This is a multi-center, prospective, open label, non-randomized study to collect safety and effectiveness data in subjects with central sleep apnea implanted with the remedē System. At least 500 subjects will be successfully implanted at approximately 50 sites in the United States and Europe.

Official Title
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Prospective Non-randomized Post Market Study Collecting Clinical Data on Safety and Effectiveness of the remedē® System

Conditions
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Central Sleep Apnea

Intervention / Treatment
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* Device: remede System


Participation Criteria
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Eligibility Criteria
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Moderate to severe central sleep apnea (AHI ≥ 15 events per hour) based on a sleep study scored by a local sleep laboratory. It is strongly recommended that a patient have a diagnostic PSG within 12 months of the expected implant date documenting moderate to severe CSA. Age 18 years or older Signed Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent In the opinion of the investigator, subject is willing and able to comply with the protocol. Not currently enrolled in another investigational study or registry that would directly interfere with the current study, except if the subject is participating in a mandatory government registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility. In the opinion of the Investigator, life expectancy exceeds one year. The subject is not pregnant or planning to become pregnant.

Ages Eligible for Study
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Minimum Age: 18 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

| Intervention/Treatment |
| --- |
|Device: remede System|Patients undergoing a remede System implant attempt. Study devices will be used per approved indications for use for each geography.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate safety of the remedē System at implant and protocol required follow up by assessment of serious adverse events (SAEs) related to procedure, device, or delivered therapy | Proportion of subjects with peri-operative and long-term serious adverse events (SAEs) related to the remedē System implant procedure, device or delivered therapy | 5 years | 
| Evaluate changes in sleep disordered breathing metrics after 12 months of therapy | Change from baseline to 12-month visit for the following sleep metrics measured during in-lab polysomnogram (PSG): apnea hypopnea index (AHI), central apnea index (CAI), oxygen desaturation index 4% (ODI4) and percent of sleep with oxygen saturation <90% | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate safety of the remedē System by assessment of non-serious AE related to procedure, device or delivered therapy | Proportion of subjects with non-serious AEs related to the remedē System implant procedure, device or delivered therapy | 5 years | 
| Evaluate changes in sleep disordered breathing metrics after 36 and 60 months of therapy | Change from baseline to 36- and 60-month visits for the following sleep metrics during an at home sleep apnea test (HSAT): apnea hypopnea index (AHI), central apnea index (CAI), oxygen desaturation index 4% (ODI4), percent of sleep with oxygen saturation <90% | 36 and 60 months |