Post Approval Study of the remedē System

Completed

Conditions studied: Central Sleep Apnea

In brief

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

Key facts

Study ID

NCT03425188

Run by

Respicardia, Inc.

People needed

53

Starts

2018-06-28

Expected to finish

2020-08-04

Last updated by the study team

2021-04-22

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Keck Medical Center of USC — Los Angeles, California, United States
• UF Health Jacksonville — Jacksonville, Florida, United States
• Advocate Good Samaritan Hospital — Downers Grove, Illinois, United States
• University of Maryland, Baltimore — Baltimore, Maryland, 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 — St Louis, Missouri, United States
• Nebraska Heart Institute — Lincoln, Nebraska, United States
• Cooper Health System — Cherry Hill, New Jersey, United States
• Novant Clinical Research Institute Forsyth Medical Center — Winston-Salem, North Carolina, United States
• The Lindner Center for Research & Education at The Christ Hospital — Cincinnati, Ohio, United States
• The Ohio State University — Columbus, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Wesley Neurology — Cordova, Tennessee, United States
• Methodist Hospital — San Antonio, Texas, United States
• Marshfield Clinic — Marshfield, Wisconsin, United States
• Herz-und Diabeteszentrum NRW — Bad Oeynhausen, Germany

Full record on ClinicalTrials.gov

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