remedē System Therapy Study (rēST)

Prospective Non-randomized Post Market Study Collecting Clinical Data on Safety and Effectiveness of the remedē® System

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Central Sleep Apnea
• Intervention / Treatment: Device: remede System

Detailed 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. A sub-study involving the WatchPAT device will be performed in a subset of sites.

• Study Type: Observational
• Enrollment (Estimated): 225

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1061AE
    • OLVG Amsterdam
  • Breda, Netherlands, 4818 CK
    • Amphia Longresearch
  • Enschede, Netherlands, 7512 KZ
    • Medisch Spectrum Twente
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Arizona Heart Rhythm Center
    • Phoenix, Arizona, United States, 85006
      • Banner University Medical Center
    • Scottsdale, Arizona, United States, 85258
      • Honorhealth
  • California
    • San Francisco, California, United States, 94143
      • The University of California San Francisco
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado- Anschutz
    • Fort Collins, Colorado, United States, 80528
      • University of Colorado Health
  • Florida
    • Orlando, Florida, United States, 32803
      • Central Florida Pulmonary Group
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Emory University Midtown Hospital
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Baptist Health Lexington
  • Michigan
    • Wyoming, Michigan, United States, 49519
      • University of Michigan Health West
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • St. Luke's Mid America Heart Institute
  • New Jersey
    • Paramus, New Jersey, United States, 07652
      • The Valley Hospital
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • New Mexico Heart Institute - Lovelace Medical Center
  • New York
    • New Hyde Park, New York, United States, 11040
      • Northwell Health
    • New York, New York, United States, 10065
      • New York Presbyterian Hospital-Weill Cornell Medicine
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Novant Health - Charlotte
    • Greenville, North Carolina, United States, 27834
      • East Carolina University
    • Winston-Salem, North Carolina, United States, 27103
      • Novant Health Forsyth Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State Wexner Medical Center
    • Dublin, Ohio, United States, 43017
      • Ohio Sleep Medicine Institute
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • Oklahoma Heart Institute
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Health Milton S. Hershey Medical Center
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Monument Health
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor Scott and White - Dallas
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate safety of the remedē System by assessment of non-serious AE related to procedure, device or delivered therapy	Proportion of subjects with non-serious AEs related to the remedē System implant procedure, device or delivered therapy	5 years
Evaluate changes in sleep disordered breathing metrics after 36 and 60 months of therapy	Change from baseline to 36- and 60-month visits for the following sleep metrics during an at home sleep apnea test (HSAT): apnea hypopnea index (AHI), central apnea index (CAI), oxygen desaturation index 4% (ODI4), percent of sleep with oxygen saturation <90%	36 and 60 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate changes in daytime sleepiness through 12 months	Epworth Sleepiness Scale (ESS) change from baseline to 12-month visit	12 months
Evaluate changed in quality of life (QOL) through 12 months	Quality of life assessment including the following: Kansas City Cardiomyopathy Questionnaire (KCCQ) change from baseline at 12 months (HF subgroup only); PROMIS-29 questionnaire change from baseline at 12, months; Patient Global Assessment (PGA) at 12 months	12 months
Evaluate changes in left ventricular ejection fraction in the HF subgroup after 12 months of therapy	Change in left ventricular ejection fraction based on echocardiographic assessment in the HF subgroup from baseline to 12 months.	12 months

Collaborators and Investigators

• Sponsor: Respicardia, Inc.
• Investigators: Study Director: Kathy McPherson, ZOLL Respicardia, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2019
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2030

Study Registration Dates

• First Submitted: March 19, 2019
• First Submitted That Met QC Criteria: March 20, 2019
• First Posted (Actual): March 21, 2019

Study Record Updates

• Last Update Posted (Actual): July 24, 2025
• Last Update Submitted That Met QC Criteria: July 21, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Central
• Other Study ID Numbers: CIP1393

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes