Janus Feasibility Study

Study Overview
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Brief Summary
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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.

Official Title
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Transvenous Nerve Stimulation Study (Janus Study)

Conditions
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Sleep Apnea Syndromes

Intervention / Treatment
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* Device: Transvenous nerve stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is at least 18 years old Subject with moderate to severe central sleep apnea is undergoing a de novo commercial remedē® System implant procedure or other de novo transvenous cardiac implantable device procedure including a pacemaker or an implantable cardiac defibrillator Subject is willing and able to give informed consent Exclusion Criteria: Subject is unable or unwilling to participate with study procedures or in the investigator's opinion is medically unstable for the procedure (Medically unstable is defined as when a patient is expected to have worsening health status if additional procedure time is needed) Subject is pregnant or planning to become pregnant (all women with childbearing potential must have a negative pregnancy test within 7 days prior to the implant) Subject is known to be allergic to radio opaque dye which cannot safely be pre-treated per the investigator Subject has body mass index (BMI) > 40 kg/m2 at the time of implant Subject has had prior neck surgery Previous or currently implanted upper airway stimulation device Subject has had prior oral cavity surgery that may interfere with breathing Subject has significant upper airway-related anatomic anomaly Subject is enrolled in concurrent study that may confound the results of this study Subject is taking muscle relaxant medication unless approved by the site implanter and ZOLL Respicardia clinical staff Subject has evidence of nerve weakness/paresis/paralysis or a neurologic disorder that involves the tongue

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: This is an acute, prospective, non-randomized, single arm IDE feasibility study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transvenous nerve stimulation<br> | Device: Transvenous nerve stimulation<br>* Acute transvenous nerve stimulation during a commercial implant of remedē® System or commercial transvenous cardiac device (de novo pacemaker or implantable cardiac defibrillator).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in respiration and airway physiology | The primary objective is to assess acute changes in respiration and airway physiology during the respiration cycle during a commercial remedē® System or commercial transvenous cardiac device (de novo pacemaker or implantable cardiac defibrillator) implant. | During procedure (immediately post-stimulation) |