Respicardia, Inc. Pivotal Trial of the remedē System

Inclusion Criteria

• At least 18 years of age
• Central Sleep apnea confirmed by core lab analysis of PSG with EEG within 40 days of scheduled implant:
• Apnea/Hypopnea Index (AHI) greater than or equal to 20;
• Central Apnea Index (CAI) at least 50% of all apneas, with at least 30 central apnea events;
• Oxygen Desaturation Index (OAI) less than or equal to 20% of the total AHI
• Medically stable for 30 days prior to all baseline testing (including PSG), i.e., no hospitalizations for illness, no breathing mask-based therapy, and on stable medications and therapies:
• Stable medications are defined as no changes during this period except for those within a pre-specified sliding scale medication regimen;
• If the subject has heart failure, the baseline testing (including PSG) should occur at least 6 months after initial diagnosis;
• If the subject has systolic heart failure, the baseline testing (including PSG) should occur after maximally titrating beta blockers, angiotensin converting enzyme inhibitors (ACE-I) and other medications indicated in the current guidelines (unless contraindicated or not considered medically necessary) and after receiving any indicated device therapy including devices for cardiac resynchronization therapy and/or primary prevention of sudden cardiac death;
• If subject has a hospitalization or physician visit requiring IV medication between the screening PSG and implant, the subject must be re-screened when stable
• Expected to tolerate study procedures in the opinion of the investigator, in particular:
• Ability to lie down long enough to insert the remede system without shortness of breath and able to tolerate instrumentation for the Polysomnogram/Polygram testing;
• Expected to tolerate therapy titration and the sensation of therapy, and communicate therapy experience.
• In the investigator's opinion, willing and able to comply with all study requirements
• Signed the Institutional Review Board/Medical Ethics Committee approved informed consent (HIPAA authorization in the U.S.)

Exclusion Criteria

• Pacemaker dependent subjects without any physiologic escape rhythm
• Suspected inability to place catheter for delivery of stimulation lead (e.g. previously know coagulopathy, distorted anatomy, prior failed pectoral implant, etc.)
• Evidence of phrenic nerve palsy
• More than 2 previous open chest surgical procedures (e.g., CABG)
• Etiology of central sleep apnea known to be caused primarily by pain medication
• Documented history of psychosis or severe bipolar disorder
• Cerebrovascular accident (CVA) within 12 months of baseline testing
• History of idiopathic pulmonary hypertension, World Health Organization Class 1
• Limited pulmonary function with either forced expiratory volume (FEV) 1/forced vital capacity (FVC) less than 65% of predicted value or FVC less than 60% of predicted value
• Baseline oxygen saturation less than 92% while awake and on room air after 5 minutes of quiet rest
• Anticipated need for chronic oxygen therapy or breathing mask-based therapy for 6 months post therapy initiation visit
• Active infection or sepsis within 30 days of enrollment
• Currently on renal dialysis or creatinine level greater than 2.5 mg/dL or calculated creatinine clearance equal to or less than 30 ml/min using the Cockcroft-Gault equation
• Poor liver function with baseline aspartate transaminase (AST), alanine transaminase (ALT), and/or total bilirubin greater than 3 times the upper limit of normal (per lab normals at each site)
• Hemoglobin less than 8 gm/dL
• In subjects with heart failure, American College of Cardiology (ACC)/American Heart Association Heart (AHA) Stage D
• Within the 3 months prior to baseline testing, any of the following: uncorrected severe valvular stenosis, valve replacement or repair (percutaneous or surgical), myocardial infarction (MI), coronary artery bypass grafting (CABG) surgery, percutaneous coronary intervention (PCI), cardiac abla