Respicardia, Inc. Pivotal Trial of the remedē System
Public ClinicalTrials.gov record NCT01816776. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized Trial Evaluating the Safety and Effectiveness of the remedē® System in Patients With Central Sleep Apnea
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary purpose of this prospective, multicenter, randomized trial is to evaluate the safety and effectiveness of therapy delivered by the remedē® system in subjects with moderate to severe central sleep apnea and optimal medical management, compared to outcomes in randomized control subjects receiving optimal medical management and implanted but inactive remedē® systems.
Study identification
- NCT ID
- NCT01816776
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 151 participants
Conditions and interventions
Interventions
- Treatment Group (transvenous stimulation of the phrenic nerve) Device
- Control Group (Optimal Medical Therapy) Device
Device
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 2013 (Type not available)
- Primary completion
- Sep 10, 2016 (Actual)
- Completion
- Nov 7, 2017 (Actual)
- Last update posted
- Jun 29, 2018
2013 – 2017
United States locations
- U.S. sites
- 23
- U.S. states
- 16
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Keck Hospital of USC | Los Angeles | California | 90033 | — |
| University of Florida - Jacksonville | Jacksonville | Florida | 32209 | — |
| Advocate Medical Group | Downers Grove | Illinois | 60566 | — |
| Edward Hospital-Advocate Medical Group | Naperville | Illinois | 60566 | — |
| University of Maryland, Baltimore | Baltimore | Maryland | 21201 | — |
| Johns Hopkins Bayview Medical Center | Baltimore | Maryland | 21287 | — |
| Detroit Clinical Research Center | Farmington Hills | Michigan | 48334 | — |
| Spectrum Health | Grand Rapids | Michigan | 49525 | — |
| United Heart and Vascular (Allina) | Saint Paul | Minnesota | 55102 | — |
| Mid America Heart Institute | Kansas City | Missouri | 64111 | — |
| Washington University | St Louis | Missouri | 63110 | — |
| Bryan Heart | Lincoln | Nebraska | 68506 | — |
| Cooper Health System | Cherry Hill | New Jersey | 08034 | — |
| Novant Medical Group, Inc. Presbyterian Sleep Health Charlotte | Charlotte | North Carolina | 28204 | — |
| Forsyth Medical Center - Novant | Winston-Salem | North Carolina | 27103 | — |
| The Lindner Center for Research and Education at Christ Hospital | Cincinnati | Ohio | 45219 | — |
| Ohio State University | Columbus | Ohio | 43210 | — |
| Lancaster General Hospital | Lancaster | Pennsylvania | 17603 | — |
| Hospital of University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Stern Cardiovascular | Memphis | Tennessee | 38138 | — |
| Methodist Healthcare System | San Antonio | Texas | 78229 | — |
| Virginia Commonwealth University | Richmond | Virginia | 23219 | — |
| Marshfield Clinic | Marshfield | Wisconsin | 54449 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01816776, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 29, 2018 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01816776 live on ClinicalTrials.gov.