Lead Sponsor

Respicardia, Inc.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

•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

•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

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