remedē System Therapy Study
Purpose
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.
Condition
- Central Sleep Apnea
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Respicardia, Inc.
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. At least 500 subjects will be successfully implanted at approximately 50 sites in the United States and Europe.