Reduction of Ventricular Rate During Atrial Fibrillation by AV Node Stimulation" AVNS Download Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 8
- 主要终点
- To evaluate the performance of the investigational algorithm in reducing mean VR during AF, the relative reduction of VR during AVNS will be assessed in acute in-hospital tests, conducted preferably during either spontaneous or induced episodes of AF.
研究概览
简要总结
The aim of this multi-center research study is to evaluate the performance (primary purpose) and safety of a new algorithm aimed at controlling ventricular rate (VR) during rapidly conducted atrial fibrillation (AF) by delivering AV node stimulation (AVNS) from the atrial lead placed at a septal position, and designed with the purpose of reducing inappropriate shocks. Additional purposes include the assessment of a possible application of AVNS aimed at allowing prolonged control of VR during AF and reducing AF symptoms, and evaluation of implantation data on selective placement of the atrial lead in postero-septal right atrium. About 37 patients will be followed for half a year.
详细描述
The aim of this multi-center research study is to evaluate the performance (primary purpose) and safety of a new algorithm aimed at controlling VR during rapidly conducted AF by delivering AVNS from the atrial lead placed at a septal position, and designed with the purpose of reducing inappropriate shocks. Additional purposes include the assessment of a possible application of AVNS aimed at allowing prolonged control of VR during AF and reducing AF symptoms, and evaluation of implantation data on selective placement of the atrial lead in postero-septal right atrium. About 37 patients will be followed for half a year.
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 a documented history of paroxysmal or persistent AF are eligible to be enrolled in the study if one of the following criteria is met:
- •Indication for CRT implant according to current Guidelines (Heart Failure, NYHA III-IV class, symptomatic despite optimal stable medical therapy, left ventricular (LV) ejection fraction ≤35% and QRS≥120ms); OR
- •Indication for upgrading to CRT-D from a single chamber device; OR
- •Indication for upgrading to CRT-D from a dual chamber device with septal atrial lead or a dislodged atrial lead; OR
- •Indication for device replacement or surgical revision in patients already implanted with a CRT-D device and an atrial lead in the septal position or a dislodged atrial lead; OR
- •Patients already implanted with a ConsultaTM device and an atrial lead in the septal position, requiring electrical cardioversion.
排除标准
- •If any of the following criteria are met, patient cannot be enrolled in the study:
- •Permanent atrial fibrillation;
- •Patients who are not on anti-coagulant therapy;
- •Advanced AV block (II-III degree AV block);
- •Patients previously submitted to valvular surgery;
- •Patients previously submitted to AV or AF ablative procedures;
- •Age < 18 years;
- •Patient not disposed to sign the Informed Consent;
- •Participation in other studies which could potentially conflict with this study;
结局指标
主要结局
To evaluate the performance of the investigational algorithm in reducing mean VR during AF, the relative reduction of VR during AVNS will be assessed in acute in-hospital tests, conducted preferably during either spontaneous or induced episodes of AF.
时间窗: baseline and 1 month
次要结局
- To evaluate the performance of the investigational algorithm in shock reduction.(baseline, 1 month, 3 months, 6 months)
- To evaluate the safety of the investigational algorithm.(baseline, 1 month, 3 months, 6 months)
- To gather data for further possible applications.(baseline, 1 month, 3 months, 6 months)
- To collect data on selective placement of the atrial lead.(baseline, 1 month, 3 months, 6 months)