Post Approval Study of the remedē System

Central Sleep Apnea Clinical Trial

Official title:

Post Approval Study of the remedē System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03425188
• Other study ID #: CR1079
• Status: Completed
• Start date: June 28, 2018
• Est. completion date: August 4, 2020

Study information

• Verified date: April 2021
• Source: Respicardia, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: August 4, 2020
• Est. primary completion date: August 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Subjects who were previously implanted with the remede System and participated in the remede 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

Related Conditions & MeSH terms

• Central Sleep Apnea
• Sleep Apnea, Central

Locations

Country	Name	City	State
Germany	Herz-und Diabeteszentrum NRW	Bad Oeynhausen
United States	University of Maryland, Baltimore	Baltimore	Maryland
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	The Ohio State University	Columbus	Ohio
United States	Wesley Neurology	Cordova	Tennessee
United States	Advocate Good Samaritan Hospital	Downers Grove	Illinois
United States	UF Health Jacksonville	Jacksonville	Florida
United States	Saint Luke's Hospital of Kansas City	Kansas City	Missouri
United States	Nebraska Heart Institute	Lincoln	Nebraska
United States	Keck Medical Center of USC	Los Angeles	California
United States	Marshfield Clinic	Marshfield	Wisconsin
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Washington University in St. Louis	Saint Louis	Missouri
United States	United Heart and Vascular Clinic	Saint Paul	Minnesota
United States	Methodist Hospital	San Antonio	Texas
United States	Novant Clinical Research Institute Forsyth Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Respicardia, Inc.

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5-Year Survival Rate	Assessment of survival in subjects with moderate to severe central sleep apnea being treated with the remede 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
Primary	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
Primary	Number of Participants With Therapy-related Serious Adverse Events (SAEs) Through Three and Five Years	Assessment of the safety of the remede 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
Primary	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
Primary	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