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

• Left ventricular end-systolic dimension (LVESD) [ Time Frame: 6-months post-implant ] [ Designated as safety issue: No ]
  Echocardiography LVESD
• All-cause mortality [ Time Frame: 18-months post-implant ] [ Designated as safety issue: Yes ]
  All-cause mortality

• Left ventricular remodeling [ Time Frame: 6-months post-implant ] [ Designated as safety issue: No ]
  Echocardiography parameters of left ventricular structure and function (e.g., LVEF, LVESV and LVEDV, LVEDD)
• Functional capacity [ Time Frame: 6-months post-implant ] [ Designated as safety issue: No ]
  Assessment of functional capacity (e.g., peak VO2, anaerobic threshold)
• Quality of Life [ Time Frame: 6-months post-implant ] [ Designated as safety issue: No ]
  Assessments of patient reported quality of life (i.e., MLWHFQ and SF-36)
• Heart failure status [ Time Frame: 6-months post-implant ] [ Designated as safety issue: No ]
  Assessment of heart failure status (i.e., NYHA Class)

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.

The objectives of this study are to assess the impact of right vagal nerve stimulation on left ventricular remodeling, functional capacity, quality of life, and other measures in heart failure patients over a 6-month period. In addition, the study will assess the safety of the NECTAR-HF study system over an 18-month period.

• Heart Failure
• Congestive Heart Failure

• Experimental: Therapy
  Intervention: Device: Vagal Nerve Stimulation
• No Intervention: Control
  Control group will be implanted with study system, but will receive no therapy until 6-month cross-over.

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 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 180 days prior to enrollment
• Pacemaker indicated patients
• Patients whose heart failure is due to congenital heart disease
• Patients actively treated for sleep apnea or sleep disordered breathing with therapies to maintain airway patency with or without oxygen supplementation
• 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
• Insulin-dependent diabetic patients
• 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
• Patients who, in the best clinical judgment of the investigator, are indicated for cardiac resynchronization therapy (CRT)
• Patients with locally implanted semi/permanent devices such as vascular catheters, etc.
• 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
• 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