Synchronized Diaphragmatic Stimulation in Symptomatic Heart Failure

Prior treatment

• Any of the following within the previous 3 months: unstable angina, AMI, CABG, PTCA, CVA/TIA, AF (episodes \> 24 hours), symptomatic NSVT or DCCV
• Any inotropic drug treatment within the previous 3 months
• Significant uncontrolled symptomatic bradyarrhythmia, atrial fibrillation, unstable ventricular arrhythmias or frequent ventricular ectopy \> 10% documented within the previous 3 months
• Presence of more than small pleural effusion or history of pleural drainage within the previous 6 months
• Present LVAD, Baroreflex Activation Therapy, Cardiac Contractility Modulation or interatrial shunt devices; temporary mechanical cardiac assist devices (current or within the previous 3 months)
• Previous open laparotomy within 1 year
• Previous thoracic or abdominal organ transplant
• Drug induced immuno-suppression
• Enrollment in a concurrent investigation / clinical study
• History of systemic infection requiring the use of intravenous antibiotics within the previous 3 months
• Received cardiac resynchronization therapy (CRT) within six months of randomization, or is actively receiving CRT

Other illness

• Supine resting heart rate \> 140 bpm
• Bradycardia (heart rate \< 50 beats/min), atrial arrhythmias with rates \> 100 beats/min, sustained ventricular tachycardia or frequent ventricular ectopy \>10% present during screening
• Valvular disease requiring intervention within the next 12 months or presence of significant valve disease as determined by the site cardiologist as:
  • Greater than mild mitral valve stenosis
  • Greater than moderate mitral valve regurgitation
  • Greater than mild tricuspid valve stenosis
  • Greater than moderate-severe tricuspid valve regurgitation
  • Greater than moderate aortic stenosis
  • Greater than moderate aortic regurgitation
  • Greater than mild-moderate pulmonic stenosis
  • Greater than moderate pulmonic regurgitation
• Severe primary pulmonary disease, including pulmonary arterial hypertension. PAP sys \>70 mmHg at rest
• Severe COPD, other respiratory or lung diseases where FEV1 \< 50%
• Known history of diaphragmatic paralysis or suspicion confirmed by unilateral or bilateral elevation of the diaphragm on chest x-ray
• Pericardial disease
• Non-cardiac condition substantially impairing ambulation of 6-minute hall walk test interpretation
• Having a life expectancy of \<1 year due to any condition
• Known allergies to implantable device materials
• Currently have a Class I indication for a cardiac resynchronization therapy (CRT) device according to AHA/ACC/ESC guidelines for the treatment of congestive heart failure

Lab values

• Serum creatinine \> 2.5 mg/dL
• Serum hepatic function 3x ULN

Other

• Baseline 6-minute walk test \> 500 meters or \< 200 meters
• NT-proBNP\< 250 if on loop diuretics, or NT-proBNP \< 500 if not on loop diuretics
• Systolic blood pressure \< 80 mmHg or \> 170 mmHg
• Reversible non-ischemic cardiomyopathy
• Existing diaphragmatic stimulation for respiration assist
• Contraindications to laparoscopic access to the diaphragm, as determined by the implanting physician
• Known intra-abdominal pathology which could increase the risk of laparoscopic access to the diaphragm.
• Body mass index \> 40
• Pregnant or planning a pregnancy during the study period

• NYHA classes II/III on optimal Guideline Directed Medical Therapy (GDMT) for 3 months
• EF≤ 40%
• At the time of consent, willing and able to comply with protocol requirements, including attending all required visits
• Willing to participate in the study and able to sign an informed consent form
• ≥18 years of age at the time of consent