Synchronized Diaphragmatic Stimulation in Symptomatic Heart Failure

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Supine resting heart rate > 140 bpm
• Systolic blood pressure \< 80 mmHg or > 170 mmHg
• Serum creatinine > 2.5 mg/dL
• Serum hepatic function 3x ULN
• 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
• Bradycardia (heart rate \< 50 beats/min), atrial arrhythmias with rates > 100 beats/min, sustained ventricular tachycardia or frequent ventricular ectopy >10% present during screening
• Significant uncontrolled symptomatic bradyarrhythmia, atrial fibrillation, unstable ventricular arrhythmias or frequent ventricular ectopy > 10% documented within the previous 3 months
• Reversible non-ischemic cardiomyopathy
• 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%
• Presence of more than small pleural effusion or history of pleural drainage within the previous 6 months
• 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
• Existing diaphragmatic stimulation for respiration assist
• Present LVAD, Baroreflex Activation Therapy, Cardiac Contractility Modulation or interatrial shunt devices; temporary mechanical cardiac assist devices (current or within the previous 3 months)
• 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.
• Previous open laparotomy within 1 year
• Previous thoracic or abdominal organ transplant
• Drug induced immuno-suppression
• Body mass index > 40
• Enrollment in a concurrent investigation / clinical study
• Having a life expectancy of \<1 year due to any condition
• Pregnant or planning a pregnancy during the study period
• Known allergies to implantable device materials
• 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
• 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