remedē System Therapy Study
NCT03884660 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 225
Last updated 2025-07-24
Summary
The purpose of this non-randomized post market study is to collect clinical data on the safety and effectiveness of the remedē System in a real-world setting.
Conditions
- Central Sleep Apnea
Interventions
- DEVICE
-
remede System
Patients undergoing a remede System implant attempt. Study devices will be used per approved indications for use for each geography.
Sponsors & Collaborators
-
Respicardia, Inc.
lead INDUSTRY
Principal Investigators
-
Kathy McPherson · ZOLL Respicardia, Inc.
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-06-18
- Primary Completion
- 2026-06-30
- Completion
- 2030-12-30
- FDA Device
- Yes
Countries
- United States
- Netherlands
Study Locations
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