Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF)

The NECTAR-HF feasibility trial is designed to evaluate the application of right vagal nerve stimulation in heart failure patients with a New York Heart Association Class III, an ejection fraction equal to or less than 35 %, and a narrow QRS duration equal to or less than 130 ms.

Inclusion Criteria: * Age 18 or above, and of legal age to give informed consent specific to national laws * Willing and capable of providing informed consent * Capable of participating in all testing associated with this clinical investigation * Stable symptomatic heart failure NYHA class II-III * Left ventricular (LV) ejection fraction equal or smaller than 35 % * Left ventricular end diastolic diameter (LVEDD) of 5.5 cm or greater * Prescribed to optimal pharmacologic therapy Exclusion Criteria: * QRS larger than 130 ms * Patients who have been hospitalized for heart failure and who required the use of HF IV therapy within 30 days before enrollment * Patients unable to tolerate anesthesia required for implant * Patients with unstable angina, myocardial infarction, PTCA, coronary artery bypass graft, cerebral vascular accident, or transient ischemic attack within previous 90 days before enrollment * Patients whose primary cause of heart failure is mitral or aortic valve disease, with a severe classification * Patients with persistent or permanent atrial fibrillation within 90 days prior to enrollment * Pacemaker indicated patients * Patients whose heart failure is due to congenital heart disease * Patients who have started treatment for sleep apnea or sleep disordered breathing with therapies to maintain airway patency (e.g., CPAP, Bi-PAP,APAP) with or without oxygen supplementation within the previous 6 months prior to enrollment * Patients with hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g. amyloidosis, sarcoidosis) * Patients with documented chronic obstructive lung disease * Patients on or indicated for renal dialysis * Type 1 diabetic patients * Type 2 diabetic patients that have been treated with insulin for more than 5 years prior to enrollment * Patients with a life expectancy of less than 12 months per physician judgment * Patients involved in any concurrent clinical investigation * Women of childbearing potential who are or might be pregnant at the time of the study or breastfeeding * Patients with a prior cardiac transplant or expecting a heart transplant operation within the next 12 months * Patients with a prior vagotomy * Patients with prior or existing vagal nerve stimulation treatment * Patients implanted with any active implantable medical device other than a left sided single or dual chamber implantable cardioverter defibrillator (ICD) with bipolar sensing, or a left sided CRT device with each sensing channel programmed to either bipolar sensing or no sensing. All CRT patients must have had CRT for at least 1 year prior to enrollment. The total number of CRT patients will not exceed 30 * Patients with locally implanted semi-/permanent devices such as vascular catheters, etc. that would interfere with the NECTAR-HF study system * Patients with previously implanted devices on the right side that became infected before removal * Patients with previous neck surgery and resultant scar formation that interferes with the ability to implant the study system on the right side of the neck (Thyroid/parathyroid, carotid artery etc) * Patients with known recurrent nerve paralysis * Patients who have undergone radiotherapy for thyroid disease/cancer * Patients who have existing or prior tracheotomy * Patients with severe vertebral cervical disease and limited mobility in the neck; includes those that frequently wear a brace * Patients with carotid murmur/vascular bruit/carotid artery lesion * Patients with known/suspected vascular malformation in carotid/vertebral circulatory bed * Patients who are likely to need an MRI of the neck area because of previous medical conditions