remedē System Therapy Study

Last updated: February 5, 2025
Sponsor: Respicardia, Inc.
Overall Status: Active - 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: 500
Treatment Group(s): 1
Primary Treatment: remede System
Phase:
Study Start date:
June 18, 2019
Estimated Completion Date:
June 30, 2032

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. At least 500 subjects will be successfully implanted at approximately 50 sites in the United States and Europe.

Connect with a study center

  • OLVG Amsterdam

    Amsterdam, 1061AE
    Netherlands

    Active - Recruiting

  • Amphia Longresearch

    Breda, 4818 CK
    Netherlands

    Active - Recruiting

  • Medisch Spectrum Twente

    Enschede, 7512 KZ
    Netherlands

    Active - Recruiting

  • Arizona Heart Rhythm Center

    Phoenix, Arizona 85016
    United States

    Terminated

  • Banner University Medical Center

    Phoenix, Arizona 85006
    United States

    Terminated

  • HonorHealth

    Scottsdale, Arizona 85258
    United States

    Active - Recruiting

  • The University of California San Francisco

    San Francisco, California 94143
    United States

    Active - Recruiting

  • University of Colorado- Anschutz

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • University of Colorado Health

    Fort Collins, Colorado 80528
    United States

    Active - Recruiting

  • Central Florida Pulmonary Group

    Orlando, Florida 32803
    United States

    Active - Recruiting

  • Emory University Midtown Hospital

    Atlanta, Georgia 30329
    United States

    Active - Recruiting

  • St. Luke's Regional Medical Center

    Boise, Idaho 83712
    United States

    Site Not Available

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Terminated

  • Baptist Health Lexington

    Lexington, Kentucky 40503
    United States

    Active - Recruiting

  • Metro Health

    Wyoming, Michigan 49519
    United States

    Active - Recruiting

  • University of Michigan Health West

    Wyoming, Michigan 49519
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • St. Luke's Mid America Heart Institute

    Kansas City, Missouri 64111
    United States

    Terminated

  • The Valley Hospital

    Paramus, New Jersey 07652
    United States

    Terminated

  • New Mexico Heart Institute - Lovelace Medical Center

    Albuquerque, New Mexico 87102
    United States

    Active - Recruiting

  • Northwell Health

    New Hyde Park, New York 11040
    United States

    Terminated

  • New York Presbyterian Hospital-Weill Cornell Medicine

    New York, New York 10065
    United States

    Active - Recruiting

  • Novant - Charlotte

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

  • Novant Health - Charlotte

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

  • East Carolina University

    Greenville, North Carolina 27834
    United States

    Active - Recruiting

  • Novant Health Forsyth Medical Center

    Winston-Salem, North Carolina 27103
    United States

    Active - Recruiting

  • The Ohio State Wexner Medical Center

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Ohio Sleep Medicine Institute

    Dublin, Ohio 43017
    United States

    Active - Recruiting

  • Oklahoma Heart Institute

    Tulsa, Oklahoma 74104
    United States

    Active - Recruiting

  • Penn State Health Milton S. Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Active - Recruiting

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • Monument Health

    Rapid City, South Dakota 57701
    United States

    Active - Recruiting

  • Baylor Scott and White - Dallas

    Dallas, Texas 75246
    United States

    Active - Recruiting

  • West Virginia University

    Morgantown, West Virginia 26506
    United States

    Active - Recruiting

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