NCT03884660

remedē System Therapy Study

Prospective Non-randomized Post Market Study Collecting Clinical Data on Safety and Effectiveness of the remedē® System

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 225 (estimated)
• Sponsor: Respicardia, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multi-center, prospective, open label, non-randomized study to collect safety and effectiveness data in subjects with central sleep apnea implanted with the remedē System. Approximately 225 subjects will be enrolled and implanted at approximately 50 sites in the United States and Europe. A sub-study involving the WatchPAT device will be performed in a subset of sites.

Conditions

• Central Sleep Apnea

Interventions

Type	Name	Description
DEVICE	remede System	Patients undergoing a remede System implant attempt. Study devices will be used per approved indications for use for each geography.

Timeline

• Start date: 2019-06-18
• Primary completion: 2026-06-30
• Completion: 2030-12-30
• First posted: 2019-03-21
• Last updated: 2025-07-24

Locations

32 sites across 2 countries: United States, Netherlands

Regulatory

• FDA-regulated device study