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AV-node Stimulation Clinical Download Study to Reduce Ventricular Rate During AF (AVNS)

2014年2月14日 更新者：Medtronic BRC

Reduction of Ventricular Rate During Atrial Fibrillation by AV Node Stimulation" AVNS Download Study

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.

研究概览

地位

完全的

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (实际的)

45

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 德国
      • Aachen、德国、52074
        • Klinikum Aachen
  • 意大利
      • Firenze、意大利、50134
        • Institute of Internal Medicine and Cardiology, Firenze
      • Rome、意大利、I- 00186
        • Department of Cardiology, Ospedalis Giovanni Calibita Fatebenefratelli, Rome
  • 瑞典
      • Uppsala、瑞典、SE-751 85
        • Department of Cardiology, university hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：AVNS ON
Consulta downloaded with AVNS to provide high frequency bursting during fastly conducted AF. AVNS will be programmed on for five months. The feasibility and safety of the AVNS algorithm to reduce inappropriate shocks will be monitored.
设备：AVNS ON
Delaying the AV-node by stimulating the parasympathetic nerves innervating the AV-node with high frequency burst pacing during the refractory period of the ventricle using a standard atrial lead at a septal position.
其他名称：
  • AVNS
  • AV-node stimulation
  • parasympathetic AV-node stimulation

研究衡量的是什么？

主要结果指标

结果测量
大体时间
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.
大体时间：baseline and 1 month
baseline and 1 month

次要结果测量

结果测量
措施说明
大体时间
To evaluate the performance of the investigational algorithm in shock reduction.
大体时间：baseline, 1 month, 3 months, 6 months
assessing the number of successful rate reduction interventions by AVNS during spontaneous episodes of AF occurring during follow-up, with rapid VR due to AF conducted in the VT/FVT/VF zone;
baseline, 1 month, 3 months, 6 months
To evaluate the safety of the investigational algorithm.
大体时间：baseline, 1 month, 3 months, 6 months

To evaluate the safety of the investigational algorithm, assessing:

  • The rate of adverse device effects and serious adverse device effects related to the investigational algorithm;
  • The number of VT/VF or AT/AF episodes potentially induced or prolonged by the investigational algorithm.
baseline, 1 month, 3 months, 6 months
To gather data for further possible applications.
大体时间：baseline, 1 month, 3 months, 6 months

To gather data for further possible applications of AVNS, assessing:

  • the performance of the investigational algorithm in decreasing mean VR and standard deviation directly after 30 seconds of AVNS as compared to 30 seconds directly before algorithm intervention (baseline: all patients; 1, 3 and 6 months follow-up: patients in AF only);
  • the performance of the investigational algorithm in combination with ventricular pacing in decreasing mean VR and standard deviation directly after 30 seconds of AVNS as compared to 30 seconds directly before algorithm intervention (baseline only).
baseline, 1 month, 3 months, 6 months
To collect data on selective placement of the atrial lead.
大体时间：baseline, 1 month, 3 months, 6 months

evaluating:

  • electrical characteristics (impedance, threshold, sensing, FFRW) related to pacing and AVNS at implant (when applicable), baseline and follow-ups;
  • the percentage of atrial lead implantations with electrical characteristics suitable both for standard pacing and AVNS;
  • adverse events related to selective atrial lead placement at implant and in the follow-up;
  • mean duration of implant procedure and mean fluoroscopic time;
  • the presence of an implant learning curve.
baseline, 1 month, 3 months, 6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Medtronic BRC

调查人员

  • 首席研究员：Stephano Bianchi, MD、Department of Cardiology, Hospital Rome, ospedalis giovanni calibita fatebenefratelli

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年11月1日

初级完成 (实际的)

2013年11月1日

研究完成 (实际的)

2013年11月1日

研究注册日期

首次提交

2010年3月11日

首先提交符合 QC 标准的

2010年3月26日

首次发布 (估计)

2010年3月30日

研究记录更新

最后更新发布 (估计)

2014年2月17日

上次提交的符合 QC 标准的更新

2014年2月14日

最后验证

2014年2月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • AVNS

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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条件

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