Remedē® System Therapy Registry (rēST Registry)
Objective
The objective of this study is to collect clinical data on the safety and effectiveness of the remedē System in a real-world setting.
Eligibility
Subjects who are determined to be candidates to receive a de novo commercial implant of the remedē System are eligible for inclusion in this trial, subject to the entry criteria.
- Moderate to severe central sleep apnea (AHI > 15 events per hour with the events being predominantly central in origin) based on a PSG within 12 months of expected implant date scored by a local sleep laboratory.
- 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.
NCT ID
NCT03884660
