Post Approval Study of the remedē System

Prospective, single arm cohort study to evaluate the long-term safety, long-term effectiveness, and survival rate in subjects implanted with the remedē System.

Study Overview

• Status: Completed
• Conditions: Central Sleep Apnea

Detailed Description

This Post Approval Study is a multi-center, prospective, single arm cohort study to evaluate the long-term safety, long-term effectiveness, and survival rate in subjects implanted with the remedē System from the remedē System Pivotal Trial. Only subjects who were implanted and actively being followed as part of the remedē System Pivotal Trial are eligible. An individual subject's participation is expected to continue to five years post remedē System implant.

• Study Type: Observational
• Enrollment (Actual): 53

Contacts and Locations

Study Locations

• Germany
  • Bad Oeynhausen, Germany, 32545
    • Herz-und Diabeteszentrum NRW
• United States
  • California
    • Los Angeles, California, United States, 90033
      • Keck Medical Center of USC
  • Florida
    • Jacksonville, Florida, United States, 32209
      • Uf Health Jacksonville
  • Illinois
    • Downers Grove, Illinois, United States, 60515
      • Advocate Good Samaritan Hospital
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland, Baltimore
  • Minnesota
    • Saint Paul, Minnesota, United States, 55102
      • United Heart and Vascular Clinic
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Saint Luke's Hospital of Kansas City
    • Saint Louis, Missouri, United States, 63110
      • Washington University in St. Louis
  • Nebraska
    • Lincoln, Nebraska, United States, 68526
      • Nebraska Heart Institute
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08034
      • Cooper Health System
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Novant Clinical Research Institute Forsyth Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • The Lindner Center for Research & Education at The Christ Hospital
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
  • Tennessee
    • Cordova, Tennessee, United States, 38018
      • Wesley Neurology
  • Texas
    • San Antonio, Texas, United States, 78229
      • Methodist Hospital
  • Wisconsin
    • Marshfield, Wisconsin, United States, 54449
      • Marshfield Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Only subjects who were implanted and actively being followed as part of the remedē System Pivotal Trial are eligible for this trial.

Description

Inclusion Criteria:

• Subjects who were previously implanted with the remedē System and participated in the remedē System Pivotal Trial
• In the investigator's opinion, willing and able to comply with all study requirements
• Signed Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent (including Health Insurance Portability and Accountability Act [HIPAA] authorization in the US)

Exclusion Criteria:

• There are no criteria by which a subject would be excluded

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
remedē System Subjects; Subjects who were implanted with the remedē System and actively followed as part of the remedē System Pivotal Trial at the time of study closure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
5-Year Survival Rate	Assessment of survival in subjects with moderate to severe central sleep apnea being treated with the remedē System. The 5-year survival rate was estimated from Kaplan-Meier anlaysis, using time from implant to death, study exit or last contact. This analysis used all subjects enrolled in the original remede System Pivotal Trial.	Through 5 years
Number of Participants With Device-related Serious Adverse Events (SAEs) Through Three and Five Years	Assessment of long-term safety via a summary of anticipated or unanticipated device-related SAEs. Proportion of subjects experiencing a device related SAE through the time point of interest. This analysis combined data from the original pivotal trial and this post approval study.	Through 5 years
Number of Participants With Therapy-related Serious Adverse Events (SAEs) Through Three and Five Years	Assessment of the safety of the remedē System by evaluating anticipated or unanticipated therapy-related SAEs. Proportion of subjects experiencing a therapy related SAE through the time point of interest.	Through 3 and 5 years
Apnea-Hypopnea Index (AHI) Change From Baseline at 5 Years	Change in AHI = Year 5 index - Baseline index. The Apnea-Hypopnea Index is a measurement obtained from an overnight sleep study used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. The events were scored according to the 2007 "American Academy of Sleep Medicine manual for the scoring of sleep and associated events: rules, terminology and technical specifications" (Iber, et. al).	5 years
Epworth Sleepiness Scale (ESS) Change From Baseline at 5 Years	Change in ESS = Year 5 score - Baseline score. The ESS is an assessment to measure a subject's general level of daytime sleepiness. Scores can range from 0-24, with higher scores indicating higher level of daytime sleepiness.	5 years

Collaborators and Investigators

• Sponsor: Respicardia, Inc.
• Investigators: Study Director: Robin Germany, MD, Respicardia, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2018
• Primary Completion (Actual): August 4, 2020
• Study Completion (Actual): August 4, 2020

Study Registration Dates

• First Submitted: January 25, 2018
• First Submitted That Met QC Criteria: January 31, 2018
• First Posted (Actual): February 7, 2018

Study Record Updates

• Last Update Posted (Actual): April 22, 2021
• Last Update Submitted That Met QC Criteria: April 20, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Central
• Other Study ID Numbers: CR1079

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No