Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
225 participants
OBSERVATIONAL
2019-06-18
2030-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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remede System
Patients undergoing a remede System implant attempt. Study devices will be used per approved indications for use for each geography.
Eligibility Criteria
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Inclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Respicardia, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Kathy McPherson
Role: STUDY_DIRECTOR
ZOLL Respicardia, Inc.
Locations
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Banner University Medical Center
Phoenix, Arizona, United States
Arizona Heart Rhythm Center
Phoenix, Arizona, United States
HonorHealth
Scottsdale, Arizona, United States
The University of California San Francisco
San Francisco, California, United States
University of Colorado- Anschutz
Aurora, Colorado, United States
University of Colorado Health
Fort Collins, Colorado, United States
Central Florida Pulmonary Group
Orlando, Florida, United States
Emory University Midtown Hospital
Atlanta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Baptist Health Lexington
Lexington, Kentucky, United States
University of Michigan Health West
Wyoming, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
St. Luke's Mid America Heart Institute
Kansas City, Missouri, United States
The Valley Hospital
Paramus, New Jersey, United States
New Mexico Heart Institute - Lovelace Medical Center
Albuquerque, New Mexico, United States
Northwell Health
New Hyde Park, New York, United States
New York Presbyterian Hospital-Weill Cornell Medicine
New York, New York, United States
Novant Health - Charlotte
Charlotte, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, United States
The Ohio State Wexner Medical Center
Columbus, Ohio, United States
Ohio Sleep Medicine Institute
Dublin, Ohio, United States
Oklahoma Heart Institute
Tulsa, Oklahoma, United States
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Monument Health
Rapid City, South Dakota, United States
Baylor Scott and White - Dallas
Dallas, Texas, United States
West Virginia University
Morgantown, West Virginia, United States
OLVG Amsterdam
Amsterdam, , Netherlands
Amphia Longresearch
Breda, , Netherlands
Medisch Spectrum Twente
Enschede, , Netherlands
Countries
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References
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Goldberg LR, Fox H, Stellbrink C, Bozkurt B, Boehmer JP, Mora JI, Doshi R, Morgenthaler TI, Levy WC, Meyer TE, McKane SW, Germany R; remede System Therapy Study Group. Design of the remede System Therapy (reST) study: A prospective non-randomized post-market study collecting clinical data on safety and effectiveness of the remede system for the treatment of central sleep apnea. Sleep Med. 2022 Dec;100:238-243. doi: 10.1016/j.sleep.2022.08.026. Epub 2022 Sep 6.
Other Identifiers
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CIP1393
Identifier Type: -
Identifier Source: org_study_id
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