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Completed

NCT Number: NCT03425188

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.

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Key information

Conditions

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

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Herz-und Diabeteszentrum NRW, Bad Oeynhausen, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 5-Year Survival Rate

    Time frame: 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.

  2. Number of Participants With Device-related Serious Adverse Events (SAEs) Through Three and Five Years

    Time frame: 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.

  3. Number of Participants With Therapy-related Serious Adverse Events (SAEs) Through Three and Five Years

    Time frame: 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.

  4. Apnea-Hypopnea Index (AHI) Change From Baseline at 5 Years

    Time frame: 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. Epworth Sleepiness Scale (ESS) Change From Baseline at 5 Years

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Respicardia, Inc.

Industry

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 7, 2018
Registry last updated
Apr 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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