NCT01816776

Respicardia, Inc. Pivotal Trial of the remedē System

A Randomized Trial Evaluating the Safety and Effectiveness of the remedē® System in Patients With Central Sleep Apnea

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: Respicardia, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sleep Apnea, Central
• Sleep Disordered Breathing
• Heart Failure

Interventions

Type	Name	Description
DEVICE	Treatment Group (transvenous stimulation of the phrenic nerve)	device implant, optimal medical therapy and device initiation 1 month post implant.
DEVICE	Control Group (Optimal Medical Therapy)	device implant, optimal medical therapy and delayed device initiation (7 months post device implant)

Timeline

• Start date: 2013-03-01
• Primary completion: 2016-09-10
• Completion: 2017-11-07
• First posted: 2013-03-22
• Last updated: 2018-06-29
• Results posted: 2017-07-11

Locations

30 sites across 3 countries: United States, Germany, Poland