remedē System Therapy Study
- Conditions
- Central Sleep Apnea
- Registration Number
- NCT03884660
- Lead Sponsor
- Respicardia, Inc.
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 225
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 5 years Proportion of subjects with peri-operative and long-term serious adverse events (SAEs) related to the remedē System implant procedure, device or delivered therapy
Evaluate changes in sleep disordered breathing metrics after 12 months of therapy 12 months 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%
- Secondary Outcome Measures
Name Time Method Evaluate safety of the remedē System by assessment of non-serious AE related to procedure, device or delivered therapy 5 years Proportion of subjects with non-serious AEs related to the remedē System implant procedure, device or delivered therapy
Evaluate changes in sleep disordered breathing metrics after 36 and 60 months of therapy 36 and 60 months 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%
Trial Locations
- Locations (32)
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
University of Michigan Health West
🇺🇸Wyoming, Michigan, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
St. Luke's Mid America Heart Institute
🇺🇸Kansas City, Missouri, United States
The Valley Hospital
🇺🇸Paramus, New Jersey, United States
New Mexico Heart Institute - Lovelace Medical Center
🇺🇸Albuquerque, New Mexico, United States
Northwell Health
🇺🇸New Hyde Park, New York, United States
New York Presbyterian Hospital-Weill Cornell Medicine
🇺🇸New York, New York, United States
Novant Health - Charlotte
🇺🇸Charlotte, North Carolina, United States
East Carolina University
🇺🇸Greenville, North Carolina, United States
Novant Health Forsyth Medical Center
🇺🇸Winston-Salem, North Carolina, United States
The Ohio State Wexner Medical Center
🇺🇸Columbus, Ohio, United States
Ohio Sleep Medicine Institute
🇺🇸Dublin, Ohio, United States
Oklahoma Heart Institute
🇺🇸Tulsa, Oklahoma, United States
Penn State Health Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
Amphia Longresearch
🇳🇱Breda, Netherlands
Medisch Spectrum Twente
🇳🇱Enschede, Netherlands
Monument Health
🇺🇸Rapid City, South Dakota, United States
Baylor Scott and White - Dallas
🇺🇸Dallas, Texas, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States
OLVG Amsterdam
🇳🇱Amsterdam, Netherlands