Inclusion Criteria:
- NYHA classes II/III on optimal Guideline Directed Medical Therapy (GDMT)
- QRS duration ≤ 130 ms
- EF≤ 40%
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, persistent AF (> 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:
1. Greater than mild mitral valve stenosis
2. Greater than moderate mitral valve regurgitation
3. Greater than mild tricuspid valve stenosis
4. Greater than moderate-severe tricuspid valve regurgitation
5. Greater than moderate aortic stenosis
6. Greater than moderate aortic regurgitation
7. Greater than mild-moderate pulmonic stenosis
8. 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 FEV < 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
- Diabetic neuropathy
- 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); or CRT that is indicated or implanted and functional
- 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