Health Condition 1: null- Heart Failure
Conditions
Interventions
Intervention1: Implantable VNS Therapy System: Open-label safety follow-up study. Patients with symptomatic heart failure who have had a cervical VNS implantation on either the left side or right side
Sponsors
Cyberonics Inc
JSS Medical Research India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Patients enrolled in the study must meet all of the following criteria: 1. Willing and capable of providing informed consent 2. Completed the ENCORE Extension study (18-month study)
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria are not eligible to be enrolled in the study: 1. Patients with a life expectancy of less than 12 months per physician judgement. 2. Women of childbearing potential who are or might be pregnant at the time of the study or breastfeeding 3. Patients scheduled for Cardiac Resynchronization Therapy (CRT) in the next 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary safety objective will be the incidence of device-related complications. The primary efficacy objective is to evaluate the change in measures of cardiac function (LVESV and EF)Timepoint: Baseline, 6 and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 6-minute walkTimepoint: Baseline, 6 and 12 months;Blood biomarkers (brain natriuretic peptide, NT-proBNP, creatinineTimepoint: Baseline, 6 and 12 months;Heart rate variability (HRV)Timepoint: Baseline, 6 and 12 months;Left Ventricular End Systolic Diameter (LVESD)Timepoint: Baseline, 6 and 12 months;NYHA ClassTimepoint: Baseline, 6 and 12 months;Quality of Life based on patient questionnaireTimepoint: Baseline, 6 and 12 months | — |
Countries
India
Contacts
Public ContactDr Shariq Anwar
JSS Medical Research India Private Limited
Outcome results
None listed