Health Condition 1: null- Heart Failure
Conditions
Interventions
Intervention1: Implantable VNS therapy system
: Patients with symptomatic heart failure will undergo 6 months of Intermittent therapeutic vagus nerve stimulation.
The device being studied includes t
Sponsors
Cyberonics Inc
Max Neeman International
Eligibility
Inclusion criteria
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) 7. Left ventricular end diastolic diameter (LVEDD) >= 50 mm and 8. QRS width 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary safety endpoint will be the incidence of procedure and device-related complications. The primary efficacy endpoint is ECHO assessment of left ventricular End systolic and diastolic volumes. Timepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| NYHA ClassTimepoint: 1,3 and 6 months;Quality of Life questionnaireTimepoint: 3,6 months | — |
Countries
India
Contacts
Public ContactDr Shariq Anwar
Max Neeman International
Outcome results
None listed