Post Approval Study of the remedē System

Respicardia, Inc.53 enrolled

Overview

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

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

Conditions

Central Sleep Apnea

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (17)

Keck Medical Center of USC

Los Angeles, California, United States

UF Health Jacksonville

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: 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.

Data from ClinicalTrials.gov

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