VITARIA Registry: Observational prospective clinical registry in patients with symptomatic heart failure and implanted Cyberonics VITARIA™ System - VITARIA Registry

Cyberonics, Inc.0 个研究点目标入组 200 人开始时间: 2015年9月3日最近更新: 2024年8月19日

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•1. Age 18 or above
•2.Willing and capable of providing informed consent according to national data privacy regulations
•3.Patients with NYHA class II/III
•4.LVEF=40% by imaging method such as echocardiography, radionuclide angiography, left ventriculography, or cardiac magnetic resonance imaging, documented less than 12 weeks before implantation of VITARIA™ System
•5.Receiving optimal pharmacological heart failure therapy for at least 3 months
•6.Recent implantation of the VITARIA™ System, prior to device activation

•1.Hospitalization for heart failure and/or required the use of Heart Failure intravenous therapy in the past 30 days
•2.Severe mitral and/or any aortic valve dysfunction
•3.History of acute coronary syndrome (ACS) in the past 90 days
•4.Stroke or transient ischemic attack (TIA) in the past 90 days
•5.Coronary Artery Bypass Surgery (CABG) in the past 90 days
•6.PCI in the past 90 days
•7.Surgery for Valve replacement (Aortic or mitral valve) in the past 90 days
•8.Left ventricular end diastolic diameter (LVEDD) > 80 mm
•9.Patients who have had a cardiac resynchronization therapy (CRT) device implanted and have been actively treated with CRT for < 12 months
•10.Patients that are scheduled for CRT
•11.Patients who are listed for heart transplant or expected to be candidates for heart transplant
•12.Patients on hemodialysis or peritoneal dialysis
•13. 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 3 months

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