remedē System Therapy Study

NCT03884660 | Active Not Recruiting FDA Device

• 1 other identifier: CIP1393
• Study Type: observational
• Target: 225
• Locations: 2 countries
• Sites: 32

Brief 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.

Conditions

Central Sleep Apnea

Outcome Measures

Primary Outcomes (2)

• Evaluate safety of the remedē System at implant and protocol required follow up by assessment of serious adverse events (SAEs) related to procedure, device, or delivered therapy

  Proportion of subjects with peri-operative and long-term serious adverse events (SAEs) related to the remedē System implant procedure, device or delivered therapy

  5 years

• Evaluate changes in sleep disordered breathing metrics after 12 months of therapy

  Change from baseline to 12-month visit for the following sleep metrics measured during in-lab polysomnogram (PSG): apnea hypopnea index (AHI), central apnea index (CAI), oxygen desaturation index 4% (ODI4) and percent of sleep with oxygen saturation \<90%

  12 months

Secondary Outcomes (2)

• Evaluate safety of the remedē System by assessment of non-serious AE related to procedure, device or delivered therapy

  5 years

• Evaluate changes in sleep disordered breathing metrics after 36 and 60 months of therapy

  36 and 60 months

Other Outcomes (3)

• Evaluate changes in daytime sleepiness through 12 months

  12 months

• Evaluate changed in quality of life (QOL) through 12 months

  12 months

• Evaluate changes in left ventricular ejection fraction in the HF subgroup after 12 months of therapy

  12 months

Interventions

remede System DEVICE

Patients undergoing a remede System implant attempt. Study devices will be used per approved indications for use for each geography.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Respicardia, Inc.: lead

Study Sites (32)

Banner University Medical Center

Phoenix, Arizona, 85006, United States

Location

Arizona Heart Rhythm Center

Phoenix, Arizona, 85016, United States

Location

HonorHealth

Scottsdale, Arizona, 85258, United States

Location

The University of California San Francisco

San Francisco, California, 94143, United States

Location

University of Colorado- Anschutz

Aurora, Colorado, 80045, United States

Location

University of Colorado Health

Fort Collins, Colorado, 80528, United States

Location

Central Florida Pulmonary Group

Orlando, Florida, 32803, United States

Location

Emory University Midtown Hospital

Atlanta, Georgia, 30329, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

University of Michigan Health West

Wyoming, Michigan, 49519, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

St. Luke's Mid America Heart Institute

Kansas City, Missouri, 64111, United States

Location

The Valley Hospital

Paramus, New Jersey, 07652, United States

Location

New Mexico Heart Institute - Lovelace Medical Center

Albuquerque, New Mexico, 87102, United States

Location

Northwell Health

New Hyde Park, New York, 11040, United States

Location

New York Presbyterian Hospital-Weill Cornell Medicine

New York, New York, 10065, United States

Location

Novant Health - Charlotte

Charlotte, North Carolina, 28204, United States

Location

East Carolina University

Greenville, North Carolina, 27834, United States

Location

Novant Health Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

The Ohio State Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Ohio Sleep Medicine Institute

Dublin, Ohio, 43017, United States

Location

Oklahoma Heart Institute

Tulsa, Oklahoma, 74104, United States

Location

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Monument Health

Rapid City, South Dakota, 57701, United States

Location

Baylor Scott and White - Dallas

Dallas, Texas, 75246, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

OLVG Amsterdam

Amsterdam, 1061AE, Netherlands

Location

Amphia Longresearch

Breda, 4818 CK, Netherlands

Location

Medisch Spectrum Twente

Enschede, 7512 KZ, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 36116293 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood Sample

MeSH Terms

Conditions

Sleep Apnea, Central

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Kathy McPherson

  ZOLL Respicardia, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: March 21, 2019
• Study Start: June 18, 2019
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2030
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (3); US (29)