NCT03985527

Janus Feasibility Study

Transvenous Nerve Stimulation Study (Janus Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Respicardia, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this feasibility study is to assess whether an alternative transvenous lead location affects respiration and airway physiology during a commercial remedē® System or commercial transvenous cardiac device (de novo pacemaker or implantable cardiac defibrillator) implant procedure.

Conditions

• Sleep Apnea Syndromes

Interventions

Type	Name	Description
DEVICE	Transvenous nerve stimulation	Acute transvenous nerve stimulation during a commercial implant of remedē® System or commercial transvenous cardiac device (de novo pacemaker or implantable cardiac defibrillator).

Timeline

• Start date: 2020-01-09
• Primary completion: 2025-12-12
• Completion: 2025-12-12
• First posted: 2019-06-13
• Last updated: 2026-01-30

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study