Autonomic Regulation Therapy for treatment of Heart Failure.

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

Patients enrolled in the study must meet all of the following criteria:

1. Age 18 or above

2. Willing and capable of providing informed consent

3. Capable of participating in all testing associated with this clinical investigation

4. Prescribed to optimal pharmacologic therapy for at least 1 month and stable beta blocker therapy for at least 3 months

5. Stable symptomatic heart failure NYHA class II/III

6. Left ventricular ejection fraction (EF) <= 40%

7. Left ventricular end diastolic diameter (LVEDD) >= 50 mm and < 80 mm

8. QRS width < 130 ms

9. Physically capable and willing to perform repeated 6-minute walk tests associated with the study, and a baseline distance of between 150 and 425 meters. Symptoms limiting the duration of the 6 minute walk test must be due to heart failure alone.

Exclusion Criteria

Patients who meet any of the following criteria are not eligible to be enrolled in the study:

1. Patients who have been hospitalized for heart failure and who required the use of HF IV therapy in the past 30 days

2. Patients unable to tolerate anesthesia required for implant

3. Patients with unstable angina, myocardial infarction, PTCA, coronary artery bypass graft, cerebral vascular accident, or transient ischemic attack in the past 90 days

4. Patients with chronic atrial fibrillation (lasting more than 1 week or requiring cardioversion or pharmacologic conversion) in the past 180 days.

5. Coronary Artery Bypass Surgery (CABG), valve replacement or repair, aortic surgery or PCI) in the past 90 days or anticipated in the next 180 days

6. Patients whose primary cause of heart failure is mitral or aortic valve disease, with a severe classification

7. Patients with cardiac pacemakers, and pacemaker indicated patients

8. Patients whose heart failure is due to congenital heart disease

9. Patients who are on an organ transplant list or expected to have an organ transplant within 6 months

10. Patients who have received inotropic therapy in the past 60 days11. Patients who have had amiodarone therapy initiated in the past 60 days with a maintenance dose of over 200 mg daily

12. Patients actively treated for sleep apnea or sleep disordered breathing with therapies to maintain airway patency with or without oxygen supplementation

13. Patients with hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g. amyloidosis, sarcoidosis)

14. Patients on or indicated for renal dialysis

15. Patients with diabetes (type I or type II) that is being medically treated for autonomic or sensory neuropathy, or measured hemoglobin A1c (HbA1c) above 8.0% in the past 60 days.

16. Patients with hypotension (systolic blood pressure below 80 mmHg)

17. Patient with active peptic ulcer disease or history of upper GI bleeding, or ulcer within 6 months

18. Patients with asthma, history of severe COPD (e.g., FEV1 1.5 L) severe restrictive lung disease or oxygen dependence.

19. 1st degree AV block with PR interval 240 msec, 2nd or 3rd degree AV block

20. Patients with a life expectancy of less than 12 months per physician judgment

21. Patients involved in any concurrent clinical investigation

22. Women of childbearing potential who are or might be pregnant at the time of the study or breastfeeding

23. Patients with a prior cardiac transplant

24. Patients with congenital or acquired long QT syndrome.

25. Patients with documented recorded or suspected vasovagal syncope or vasodepressor syncope.

26. Patients who have undergone treatment by an investigational drug or device in the past 90 days

27. Patients with a prior vagotomy

28. Patients with prior or existing vagal nerve stimulation treatment

29. Patients who have a cardiac resynchronization therapy (CRT) device, or are scheduled for CRT in the next 6 months

30. Patients with locally implanted semi/permanent devices such as vascular catheters, etc.

31. Patients with previous neck surgery and resultant scar formation that interferes with the ability to implant the study system

32. Patients with known recurrent nerve paralysis33. Patients with untreated hypothyroidism or hyperthyroidism

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary safety endpoint will be the incidence of procedure and device-related complications. <br/ ><br> <br/ ><br>The primary efficacy endpoint is ECHO assessment of left ventricular End systolic and diastolic volumes. <br/ ><br>Timepoint: 6 months

Secondary Outcome Measures