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

This is an interventional treatment trial for Heart Failure focused on measuring Heart failure, Congestive heart failure, New York Heart Association Class II-III, Vagal therapy, Vagal nerve stimulation Read More

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