remedē System Therapy Study

Last updated: April 24, 2025
Sponsor: Respicardia, Inc.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Sleep Apnea Syndromes

Treatment

remede System

Clinical Study ID

NCT03884660
CIP1393
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

  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

Total Participants: 225
Treatment Group(s): 1
Primary Treatment: remede System
Phase:
Study Start date:
June 18, 2019
Estimated Completion Date:
December 30, 2030

Study 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.

Connect with a study center

  • OLVG Amsterdam

    Amsterdam, 1061AE
    Netherlands

    Site Not Available

  • Amphia Longresearch

    Breda, 4818 CK
    Netherlands

    Site Not Available

  • Medisch Spectrum Twente

    Enschede, 7512 KZ
    Netherlands

    Site Not Available

  • Arizona Heart Rhythm Center

    Phoenix, Arizona 85016
    United States

    Site Not Available

  • Banner University Medical Center

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • HonorHealth

    Scottsdale, Arizona 85258
    United States

    Site Not Available

  • The University of California San Francisco

    San Francisco, California 94143
    United States

    Site Not Available

  • University of Colorado- Anschutz

    Aurora, Colorado 80045
    United States

    Site Not Available

  • University of Colorado Health

    Fort Collins, Colorado 80528
    United States

    Site Not Available

  • Central Florida Pulmonary Group

    Orlando, Florida 32803
    United States

    Site Not Available

  • Emory University Midtown Hospital

    Atlanta, Georgia 30329
    United States

    Site Not Available

  • St. Luke's Regional Medical Center

    Boise, Idaho 83712
    United States

    Site Not Available

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Baptist Health Lexington

    Lexington, Kentucky 40503
    United States

    Site Not Available

  • Metro Health

    Wyoming, Michigan 49519
    United States

    Active - Recruiting

  • University of Michigan Health West

    Wyoming, Michigan 49519
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • St. Luke's Mid America Heart Institute

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • The Valley Hospital

    Paramus, New Jersey 07652
    United States

    Site Not Available

  • New Mexico Heart Institute - Lovelace Medical Center

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • Northwell Health

    New Hyde Park, New York 11040
    United States

    Site Not Available

  • New York Presbyterian Hospital-Weill Cornell Medicine

    New York, New York 10065
    United States

    Site Not Available

  • Novant - Charlotte

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

  • Novant Health - Charlotte

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • East Carolina University

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Novant Health Forsyth Medical Center

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • The Ohio State Wexner Medical Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Ohio Sleep Medicine Institute

    Dublin, Ohio 43017
    United States

    Site Not Available

  • Oklahoma Heart Institute

    Tulsa, Oklahoma 74104
    United States

    Site Not Available

  • Penn State Health Milton S. Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Monument Health

    Rapid City, South Dakota 57701
    United States

    Site Not Available

  • Baylor Scott and White - Dallas

    Dallas, Texas 75246
    United States

    Site Not Available

  • West Virginia University

    Morgantown, West Virginia 26506
    United States

    Site Not Available

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