CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 151 enrolled
Drug / intervention
Treatment Group (transvenous stimulation of the phrenic nerve) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01816776
NCT01816776N/ACompleted
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A Randomized Trial Evaluating the Safety and Effectiveness of the remedē® System in Patients With Central Sleep Apnea

Respicardia, Inc.·interventional·Posted Mar 22, 2013·Updated Jun 29, 2018

In Brief

A clinical study evaluating Treatment Group (transvenous stimulation of the phrenic nerve) and Control Group (Optimal Medical Therapy) for Sleep Apnea, Central and 2 related conditions. Completed, enrolled 151 participants across 30 sites in 3 countries.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSleep Apnea, Central, Sleep Disordered Breathing, Heart Failure
CountriesGermany, Poland, United States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 22, 2013
Enrollment StartMar 1, 2013
Primary CompletionSep 10, 2016
Study CompletionNov 7, 2017
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 13.3 years ago

Interventions

Treatment Group (transvenous stimulation of the phrenic nerve)device

device implant, optimal medical therapy and device initiation 1 month post implant.

Control Group (Optimal Medical Therapy)device

device implant, optimal medical therapy and delayed device initiation (7 months post device implant)