Remedē System Therapy Study

a study on Sleep Apnea Sleep Disorders

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
completion around

Description

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.

Official Title

Prospective Non-randomized Post Market Study Collecting Clinical Data on Safety and Effectiveness of the Remedē® System

Details

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.

Keywords

Central Sleep Apnea, remede System

Eligibility

For people ages 18 years and up

  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

  • The University of California San Francisco accepting new patients
    San Francisco California 94143 United States
  • Banner University Medical Center terminated
    Phoenix Arizona 85006 United States
  • Arizona Heart Rhythm Center accepting new patients
    Phoenix Arizona 85016 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Respicardia, Inc.
ID
NCT03884660
Study Type
Observational
Participants
Expecting 500 study participants
Last Updated