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NCT03425188 · ClinicalTrials.gov registry record
Post Approval Study of the remedē System
A clinical trial of Central Sleep Apnea, sponsored by Respicardia.
- Completed
- Registry status
- 53
- Enrollment target
- 17
- Study locations
NCT03425188: Completed study of Central Sleep Apnea, sponsored by Respicardia.
NCT03425188 is a study of Central Sleep Apnea that has completed, run by Respicardia. The registered enrollment target is 53 participants, below the 137-participant average among 4 other Central Sleep Apnea trials with a reported enrollment target (61% lower). The trial reports 17 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03425188, a study of Central Sleep Apnea, has completed, sponsored by Respicardia.
- COMPLETED
- Registry status
- 53 participants
- Enrollment target
- 17
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Study Locations (17)
Missouri
- Saint Luke's Hospital of Kansas City - Kansas City
- Washington University in St. Louis - St Louis
Ohio
- The Lindner Center for Research & Education at The Christ Hospital - Cincinnati
- The Ohio State University - Columbus
California
- Keck Medical Center of USC - Los Angeles
Florida
- UF Health Jacksonville - Jacksonville
Illinois
- Advocate Good Samaritan Hospital - Downers Grove
Maryland
- University of Maryland, Baltimore - Baltimore
Minnesota
- United Heart and Vascular Clinic - Saint Paul
Nebraska
- Nebraska Heart Institute - Lincoln
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2018-06-28 |
| Est. Completion | 2020-08-04 |
What the finished NCT03425188 record still lists
NCT03425188 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 137-participant average among 4 other Central Sleep Apnea trials with a reported enrollment target (61% lower).
The record links to 1 condition, with Central Sleep Apnea appearing as the primary indexed condition, and to 0 interventions.
NCT03425188 lists 17 locations in 15 states (Missouri, Ohio, California).
Frequently Asked Questions
What is clinical trial NCT03425188 about?
NCT03425188 is a clinical study titled "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.
What is the current status of trial NCT03425188?
This trial is currently completed. The enrollment target is 53 participants. The study started on 2018-06-28. Estimated completion is 2020-08-04.
What conditions does trial NCT03425188 study?
This clinical trial studies the following conditions: Central Sleep Apnea.
Who is sponsoring clinical trial NCT03425188?
This trial is sponsored by Respicardia, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03425188 being conducted?
This trial has 17 study locations across California, Florida, Illinois, Maryland, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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