Status:
COMPLETED
Post Approval Study of the remedē System
Lead Sponsor:
Respicardia, Inc.
Conditions:
Central Sleep Apnea
Eligibility:
All Genders
21+ years
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.
Detailed 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 Syst...
Eligibility Criteria
Inclusion
- 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
- There are no criteria by which a subject would be excluded
Key Trial Info
Start Date :
June 28 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 4 2020
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT03425188
Start Date
June 28 2018
End Date
August 4 2020
Last Update
April 22 2021
Active Locations (17)
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1
Keck Medical Center of USC
Los Angeles, California, United States, 90033
2
UF Health Jacksonville
Jacksonville, Florida, United States, 32209
3
Advocate Good Samaritan Hospital
Downers Grove, Illinois, United States, 60515
4
University of Maryland, Baltimore
Baltimore, Maryland, United States, 21201