CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 53 enrolled
Drug / intervention
Not specified
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/NCT03425188
NCT03425188N/ACompleted

Post Approval Study of the remedē System

Respicardia, Inc.·observational·Posted Feb 7, 2018·Updated Apr 22, 2021

In Brief

An observational study for Central Sleep Apnea. Completed, enrolled 53 participants across 17 sites in 2 countries.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesGermany, United States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedFeb 7, 2018
Enrollment StartJun 28, 2018
Primary CompletionAug 4, 2020
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 8.4 years ago