Could a diaphragm pacemaker help failing hearts?

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * NYHA classes II/III on optimal Guideline Directed Medical Therapy * QRS duration ≤ 130 ms * LVEF \< 40% * Willing and able to comply with protocol requirements, including attending all required visits * Wiling to participate in the study and able to sign an informed consent form 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 * Unstable angina, AMI, CABG, PTCA, CVA/TIA, persistent AF, NSVT or DCCV within 3 months * Intermittent IV inotropic drug treatment * Arrhythmias present during screening (profound ectopy, bradycardia, profound prevalence of ectopy, NSVT, VF, AF\*, SVT or AFLT) - \* see enrollment exception allowing for 10 patients in AF for a separate subgroup analysis * Reversible non-ischemic cardiomyopathy * Primary valvular disease * Severe primary pulmonary disease, including pulmonary arterial hypertension. PAP sys \>70 mmHg at rest * Severe COPD, other respiratory or lung diseases where FEV \< 50% * Pericardial disease * Diabetic neuropathy * Existing diaphragmatic stimulation for respiration assist * LVAD or other mechanical cardiac assist devices * 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