Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
Liviu Klein, MD
Photo of Liviu Klein
Liviu Klein

Description

Summary

The purpose of this non-randomized post market registry is to collect clinical data on the safety and effectiveness of the remedē System in a real-world setting.

Official Title

remedē System Therapy Study (rēST Study)

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 Sleep Apnea, Central remede System

Eligibility

For people ages 18 years and up

Subjects who are determined to be candidates to receive a de novo commercial implant of the remedē System are eligible for inclusion in this trial, subject to the entry criteria.

Entry 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 recommended that a patient have a 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
  • University of Colorado Health accepting new patients
    Fort Collins Colorado 80528 United States

Lead Scientist at UCSF

  • Liviu Klein, MD
    My clinical interests are heart failure and cardiac arrhythmias in patients with heart failure. Having advanced training in both heart failure and electrophysiology, I practice an integrated approach in treating patients with heart failure and cardiac arrhythmias. I am also interested in cardiac recovery using electrical (i.e. cardiac resynchronization) and mechanical (i.e.

Details

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