临床试验/NCT03163030

NCT03163030已完成不适用

Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Heart Failure With Preserved Ejection Fraction (ANTHEM-HFpEF) Study

Cyberonics, Inc.1 个研究点分布在 1 个国家目标入组 52 人开始时间: 2014年8月最近更新: 2023年5月6日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Cyberonics, Inc.
入组人数: 52
试验地点: 1
主要终点: Adverse Events

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients with symptomatic heart failure, New York Heart Association (NYHA) class II/III with preserved and mid-range EF (≥40%).

排除标准

未提供

研究组 & 干预措施

Therapy

Experimental

Right Cervical Vagus Nerve Stimulation (VNS)

干预措施: Vagus Nerve Stimulation (VNS) (Device)

结局指标

主要结局

Adverse Events

时间窗: 12 months

Incidence of procedure and device-related complications

次要结局

Cardiac Size (LAVI)(12 months)
Quality of Life Score(12 months)
Cardiac Size (LV mass index)(12 months)
Cardiac Function (E/E')(12 months)
Blood Biomarkers(12 months)
Functional Status (NYHA Class)(12 months)
Functional Status (6MWD)(12 months)
Autonomic Function (HRV)(12 months)

研究者

发起方

Cyberonics, Inc.

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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