Post Approval Study of the remedē System

Completed

Conditions: Central Sleep Apnea

Registration Number: NCT03425188

Lead Sponsor: Respicardia, Inc.

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

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 53

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 & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With Device-related Serious Adverse Events (SAEs) Through Three and Five Years	Through 5 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.
Apnea-Hypopnea Index (AHI) Change From Baseline at 5 Years	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).
Number of Participants With Therapy-related Serious Adverse Events (SAEs) Through Three and Five Years	Through 3 and 5 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.
5-Year Survival Rate	Through 5 years	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.
Epworth Sleepiness Scale (ESS) Change From Baseline at 5 Years	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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (17): Nebraska Heart Institute
🇺🇸
Lincoln, Nebraska, United States
Keck Medical Center of USC
🇺🇸
Los Angeles, California, United States
Advocate Good Samaritan Hospital
🇺🇸
Downers Grove, Illinois, United States
University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
Methodist Hospital
🇺🇸
San Antonio, Texas, United States
Novant Clinical Research Institute Forsyth Medical Center
🇺🇸
Winston-Salem, North Carolina, United States
Herz-und Diabeteszentrum NRW
🇩🇪
Bad Oeynhausen, Germany
The Ohio State University
🇺🇸
Columbus, Ohio, United States
UF Health Jacksonville
🇺🇸
Jacksonville, Florida, United States
United Heart and Vascular Clinic
🇺🇸
Saint Paul, Minnesota, United States
Saint Luke's Hospital of Kansas City
🇺🇸
Kansas City, Missouri, United States
Washington University in St. Louis
🇺🇸
Saint Louis, Missouri, United States
Wesley Neurology
🇺🇸
Cordova, Tennessee, United States
Marshfield Clinic
🇺🇸
Marshfield, Wisconsin, United States
Cooper Health System
🇺🇸
Cherry Hill, New Jersey, United States
The Lindner Center for Research & Education at The Christ Hospital
🇺🇸
Cincinnati, Ohio, United States
University of Maryland, Baltimore
🇺🇸
Baltimore, Maryland, United States