Post Approval Study of the remedē System

NCT03425188 | Completed Results

• 1 other identifier: CR1079
• Study Type: observational
• Target: 53
• Locations: 2 countries
• Sites: 17

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.

Conditions

Central Sleep Apnea

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Respicardia, Inc.: lead

Study Sites (17)

Keck Medical Center of USC

Los Angeles, California, 90033, United States

Location

UF Health Jacksonville

Jacksonville, Florida, 32209, United States

Location

Advocate Good Samaritan Hospital

Downers Grove, Illinois, 60515, United States

Location

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Location

United Heart and Vascular Clinic

Saint Paul, Minnesota, 55102, United States

Location

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Nebraska Heart Institute

Lincoln, Nebraska, 68526, United States

Location

Cooper Health System

Cherry Hill, New Jersey, 08034, United States

Location

Novant Clinical Research Institute Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

The Lindner Center for Research & Education at The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Wesley Neurology

Cordova, Tennessee, 38018, United States

Location

Methodist Hospital

San Antonio, Texas, 78229, United States

Location

Marshfield Clinic

Marshfield, Wisconsin, 54449, United States

Location

Herz-und Diabeteszentrum NRW

Bad Oeynhausen, 32545, Germany

Location

MeSH Terms

Conditions

Sleep Apnea, Central

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Limitations and Caveats

The original pivotal trial of the remede System (ClinicalTrials.gov Identifier: NCT01816776) enrolled 151 subjects and was closed following FDA approval of the PMA submission. This post approval study was initiated as a separate study to continue following as many of the 94 patients ongoing at the time of pivotal trial closure. Due to some sites declining to participate and multiple subjects declining to re-consent, the number of enrolled subjects was less than originally planned.

Results Point of Contact

• Title: Tim Meyer, VP Clinical Affairs
• Organization: Respicardia, Inc.

tmeyer@respicardia.com

952-540-4479

Study Officials

• Robin Germany, MD

  Respicardia, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2018
• First Posted: February 7, 2018
• Study Start: June 28, 2018
• Primary Completion: August 4, 2020
• Study Completion: August 4, 2020
• Last Updated: April 22, 2021
• Results First Posted: April 22, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); US (16)