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remedē System Therapy Study
remedē System Therapy Study

NCT03884660

Active Not RecruitingN/A

Sponsor: Respicardia, Inc.

Conditions: Central Sleep Apnea

Interventions: remede System

Countries: United States, Netherlands

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
1. 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.
2. Age 18 years or older
3. Signed Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent
4. In the opinion of the investigator, subject is willing and able to comply with the protocol.
5. 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.
6. In the opinion of the Investigator, life expectancy exceeds one year.
7. The subject is not pregnant or planning to become pregnant.
Locations (32)
  • Phoenix, Arizona, United States
  • Phoenix, Arizona, United States
  • Scottsdale, Arizona, United States
  • San Francisco, California, United States
  • Aurora, Colorado, United States
  • Fort Collins, Colorado, United States
  • Orlando, Florida, United States
  • Atlanta, Georgia, United States
  • Chicago, Illinois, United States
  • Lexington, Kentucky, United States
  • Wyoming, Michigan, United States
  • Rochester, Minnesota, United States
  • Kansas City, Missouri, United States
  • Paramus, New Jersey, United States
  • Albuquerque, New Mexico, United States
  • New Hyde Park, New York, United States
  • New York, New York, United States
  • Charlotte, North Carolina, United States
  • Greenville, North Carolina, United States
  • Winston-Salem, North Carolina, United States
  • Columbus, Ohio, United States
  • Dublin, Ohio, United States
  • Tulsa, Oklahoma, United States
  • Hershey, Pennsylvania, United States
  • Philadelphia, Pennsylvania, United States
  • Philadelphia, Pennsylvania, United States
  • Rapid City, South Dakota, United States
  • Dallas, Texas, United States
  • Morgantown, West Virginia, United States
  • Amsterdam, Netherlands
  • + 2 more on CT.gov