remedē System Therapy Study (rēST)

April 11, 2024 updated by: Respicardia, Inc.

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

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
      • Breda, Netherlands
        • Recruiting
        • Amphia Longresearch
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jerryl Asin, MD
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Recruiting
        • Banner University Medical Center
        • Contact:
        • Principal Investigator:
          • Joyce Lee-Iannotti
      • Phoenix, Arizona, United States, 85016
        • Recruiting
        • Arizona Heart Rhythm Center
        • Principal Investigator:
          • Vijay Swarup, MD
        • Contact:
      • Scottsdale, Arizona, United States, 85258
        • Recruiting
        • HonorHealth
        • Principal Investigator:
          • Thomas Mattioni, MD
        • Contact:
    • California
      • San Francisco, California, United States, 94143
        • Recruiting
        • The University of California San Francisco
        • Principal Investigator:
          • Liviu Klein, MD
        • Contact:
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado- Anschutz
        • Contact:
        • Principal Investigator:
          • Katherine Green
      • Fort Collins, Colorado, United States, 80528
        • Recruiting
        • University of Colorado Health
        • Contact:
        • Principal Investigator:
          • Mark Neagle, MD
    • Florida
      • Orlando, Florida, United States, 32803
        • Recruiting
        • Central Florida Pulmonary Group
        • Contact:
        • Principal Investigator:
          • Roberto Santos, MD
    • Idaho
      • Boise, Idaho, United States, 83712
        • Withdrawn
        • St. Luke's Regional Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60637
    • Kentucky
      • Lexington, Kentucky, United States, 40503
    • Michigan
      • Wyoming, Michigan, United States, 49519
        • Recruiting
        • University of Michigan Health West
        • Contact:
        • Principal Investigator:
          • Matthew Sevensma, DO
    • Minnesota
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Terminated
        • St. Luke's Mid America Heart Institute
    • New Jersey
      • Paramus, New Jersey, United States, 07652
        • Terminated
        • The Valley Hospital
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Recruiting
        • New Mexico Heart Institute - Lovelace Medical Center
        • Principal Investigator:
          • Yaw Adjei-Poku
        • Contact:
    • New York
      • New Hyde Park, New York, United States, 11040
        • Terminated
        • Northwell Health
      • New York, New York, United States, 10065
        • Recruiting
        • New York Presbyterian Hospital-Weill Cornell Medicine
        • Principal Investigator:
          • James Ip, MD
        • Contact:
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
      • Greenville, North Carolina, United States, 27834
        • Recruiting
        • East Carolina University
        • Principal Investigator:
          • Rajasekhar Nekkanti, MD
        • Contact:
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • Novant Health Forsyth Medical Center
        • Principal Investigator:
          • Michael Drucker, MD
        • Contact:
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State Wexner Medical Center
        • Principal Investigator:
          • Ralph Augostini, MD
        • Contact:
      • Dublin, Ohio, United States, 43017
        • Recruiting
        • Ohio Sleep Medicine Institute
        • Principal Investigator:
          • Asim Roy, MD
        • Contact:
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Recruiting
        • Penn State Health Milton S. Hershey Medical Center
        • Contact:
        • Principal Investigator:
          • John Boehmer, MD
      • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia, Pennsylvania, United States, 19107
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Recruiting
        • Monument Health
        • Contact:
        • Principal Investigator:
          • Ethan Levine
    • Texas
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Baylor Scott and White - Dallas
        • Contact:
        • Principal Investigator:
          • Parag Kale, MD
        • Sub-Investigator:
          • Sandra Carey, PhD
    • West Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Time Frame: 5 years
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
Time Frame: 12 months
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
Time Frame: 5 years
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
Time Frame: 36 and 60 months
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
Time Frame: 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
Time Frame: 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
Time Frame: 12 months
Change in left ventricular ejection fraction based on echocardiographic assessment in the HF subgroup from baseline to 12 months.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Respicardia, Inc.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2019

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2032

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)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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