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.
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. Approximately 225 subjects will be enrolled and implanted at approximately 50 sites in the United States and Europe. A sub-study involving the WatchPAT device will be performed in a subset of sites.
Study Type
OBSERVATIONAL
Enrollment
225
Patients undergoing a remede System implant attempt. Study devices will be used per approved indications for use for each geography.
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
Time frame: 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%
Time frame: 12 months
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
Time frame: 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%
Time frame: 36 and 60 months
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Banner University Medical Center
Phoenix, Arizona, United States
Arizona Heart Rhythm Center
Phoenix, Arizona, United States
HonorHealth
Scottsdale, Arizona, United States
The University of California San Francisco
San Francisco, California, United States
University of Colorado- Anschutz
Aurora, Colorado, United States
University of Colorado Health
Fort Collins, Colorado, United States
Central Florida Pulmonary Group
Orlando, Florida, United States
Emory University Midtown Hospital
Atlanta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Baptist Health Lexington
Lexington, Kentucky, United States
...and 22 more locations