Autonomic Regulation Therapy for treatment of Heart Failure - Extension Study
Not Applicable
- Conditions
- Health Condition 1: null- Heart Failure
- Registration Number
- CTRI/2013/11/004148
- Lead Sponsor
- Cyberonics Inc
- Brief Summary
Not available
- Detailed Description
Not available
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. Willing and capable of providing informed consent
2. Completed the ENCORE Extension study (18-month study)
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary safety objective will be the incidence of device-related complications. <br/ ><br>The primary efficacy objective is to evaluate the change in measures of cardiac function (LVESV and EF)Timepoint: Baseline, 6 and 12 months
- Secondary Outcome Measures
Name Time Method 6-minute walkTimepoint: Baseline, 6 and 12 months;Blood biomarkers (brain natriuretic peptide, <br/ ><br>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