Health Condition 1: I50- Heart failure
Conditions
Interventions
Intervention1: Implantable VNS therapy
system: Patients with symptomatic heart failure will undergo a final follow-up visit prior to study conclusion approximately 6 months after the 12-month follow-u
Sponsors
LivaNova PLC
JSS Medical Research India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Patients enrolled in the study must meet all of the following criteria: 1. Age 18 years or above 2. Willing and capable of providing informed consent 3. Capable of participating in all the testing associated with this clinical investigation 4. Chronic, symptomatic heart failure NYHA class II/III 5. Stable pharmacologic therapy for at least 1 month 6. On loop diuretic therapy for at least 1 month prior to enrollment 7. Left Ventricular Ejection Fraction (EF) >= 40% 8. Plasma NT-proBNP >= 220 pg/mL 9. Ratio of mitral velocity to early diastolic velocity of the mitral annulus (E/Eâ??) > 15, or left atrial (LA) enlargement, defined as LA volume index >= 29 mL/m2 10. Controlled systolic blood pressure (systolic BP 11. Estimated glomerular filtration rate (eGFR) >= 30 mL/min/1.73m2 at screening (calculated by the modification of Diet in Renal Disease formula) 12. 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: 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 with severe mitral (MR grade 4) or aortic valve disease 3. Patients whose heart failure is due to congenital heart disease 4. Patients with an alternative probable cause for the presenting symptoms, including but not limited to: a. Isolated right heart failure due to pulmonary disease b. Dyspnea and/or edema from non-cardiac causes, such as lung disease, anemia, or severe obesity c. Hemodynamically significant mitral and/or aortic valve disease d. Hemodynamically significant obstructive lesions of the left ventricular outflow tract, including aortic stenosis e. Hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g. amyloidosis, sarcoidosis) 5. Patients with a previous documented LVEF 6. Ratio of mitral velocity to early diastolic velocity of mitral annulus (E/Eâ??) 7. Patients with serum potassium > 5.2 mmol/L 8. Patients with unstable angina, myocardial infarction, PTCA, cerebral vascular accident, or transient ischemic attack in the past 2 months 9. Patients with chronic atrial fibrillation (lasting more than 1 week or requiring cardioversion or pharmacologic conversion) in the past 2 months, or atrial fibrillation with a resting ventricular rate of > 120 bpm 10. Patients with severe pulmonary hypertension 11. Coronary Artery Bypass Surgery (CABG), valve replacement or repair, aortic surgery or PCI) in the past 2 months or anticipated in the next 6 months 12. 1st degree AV block with PR interval > 240 msec, 2nd or 3rd degree AV block 13. Patients with congenital or acquired long QT syndrome 14. Patients unable to tolerate anesthesia required for implant 15. Patients with documented recorded or suspected vasovagal syncope or vasodepressor syncope 16. Patients with a prior vagotomy 17. Patients with prior or existing vagal nerve stimulation treatment 18. Patients with locally implanted semi/permanent devices such as vascular catheters, etc. 19. Patients with cardiac pacemakers, and pacemaker indicated patients 20. Patients who have a cardiac resynchronization therapy (CRT) device, or are scheduled for CRT in the next 6 months 21. Patients who are on an organ transplant list or expected to have an organ transplant within 6 months 22. Patients with a prior cardiac transplant 23. Patients with carotid murmur, vascular bruit, or significant carotid artery disease 24. Patients with known or suspected vascular malformation in the carotid / vertebral circulatory bed 25. Patients who have existing or prior tracheotomy 26. Patients with severe vertebral cervical disease and limited mobility in the neck; includes those that frequently wear a brace 27. Patients who are likely to need an MRI of the neck area because of previous medical conditions 28. Patients with previous neck surgery and resultant scar formation that interferes with the ability to implant the study system 29. Patients actively treated for sleep apnea or sleep disordered breathing with ther
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary safety endpoint will be the incidence of procedure and device-related adverse events.Timepoint: 18-48 months | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Left atrial volume index â?¢ 6-minute walk â?¢ Quality of Life, using the Minnesota Living with Heart Failure questionnaire â?¢ Physician and Patient Global Assessment â?¢ NYHA Class â?¢ Ratio of diastolic function (E/Eâ??) â?¢ LV mass index â?¢ Heart rate variability (HRV) â?¢ Blood biomarkers(NT-proBNP, creatinine, C-reactive protein)Timepoint: 18-48 months | — |
Countries
India
Contacts
Public ContactDr Shariq Anwar
JSS Medical Research India Private Limited
Outcome results
None listed