Autonomic Regulation Therapy in Heart Failure With Preserved Ejection Fraction
- Conditions
- Congestive Heart Failure
- Registration Number
- NCT03163030
- Lead Sponsor
- Cyberonics, Inc.
- Brief Summary
The ANTHEM-HFpEF Study is designed to demonstrate the safety and efficacy of vagus nerve stimulation (VNS) with the Cyberonics VNS Therapy System for the treatment of subjects with symptomatic heart failure with preserved and mid-range ejection fraction.
- Detailed Description
Heart failure patients will be enrolled and implanted with a cervical VNS system on the right side. After a 2-week post-implantation recovery period and a 10-week stimulation titration period, continuous periodic stimulation will be performed for 12 months, with data collection at 3, 6, 9, and 12 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
Patients with symptomatic heart failure, New York Heart Association (NYHA) class II/III with preserved and mid-range EF (≥40%).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Adverse Events 12 months Incidence of procedure and device-related complications
- Secondary Outcome Measures
Name Time Method Cardiac Size (LAVI) 12 months Left atrial volume index
Quality of Life Score 12 months Minnesota Living with Heart Failure Questionnaire score
Cardiac Function (E/E') 12 months Ratio of mitral velocity to early diastolic velocity of the mitral annulus
Cardiac Size (LV mass index) 12 months Left ventricular mass index
Blood Biomarkers 12 months Blood Levels of Heart Failure Biomarkers (NT-proBNP, creatinine, C-reactive protein)
Functional Status (NYHA Class) 12 months New York Heart Association classification
Functional Status (6MWD) 12 months 6-minute walk distance
Autonomic Function (HRV) 12 months Heart rate variability
Related Research Topics
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Trial Locations
- Locations (1)
Krishna Institute of Medical Science
🇮🇳Secunderabad, India
Krishna Institute of Medical Science🇮🇳Secunderabad, India