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临床试验/NCT03114124
NCT03114124已完成不适用

Microfidelity (MIFI) Ablation Technology Versus Standard Ablation Catheter for Atrioventricular Nodal Ablation A Comparative Pilot Study of Time to Success

University of Florida2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年5月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
The Time Differences Between the 2 Arms for Acute Success of Ablation Identified by a Junctional Rhythm or Complete Heart Block

研究概览

简要总结

The aim of our study is to investigate the comparative efficacy of high fidelity multi electrode ablation catheters vs the standard bipolar configuration in success of AV nodal ablation This study will provide insights on the use of new technology where application may increase efficacy, promote patient and physician safety and decrease costs.

详细描述

Introduction In some elderly patients with atrial fibrillation (AF), especially in combination with heart failure, a rate control strategy may be preferred. When pharmacological therapy is ineffective or not tolerated, it is reasonable to perform atrioventricular (AV) node ablation with ventricular pacing as a class IIA indication per current guidelines.

Usually, the procedure is simple and straightforward and complete heart block can be achieved without any difficulty. However, this "simple" procedure can sometimes prove to be a most difficult case. The most common reason for failure to achieve complete heart block is the inability to localize the compact AV node using the His signal with standard intracardiac electrograms. As these patients come to the laboratory in AF, the His signal may be obscured by AF waves. In some patients with a deeper intramyocardial location of the His bundle and compact AV node it becomes necessary to produce deeper ablation lesions using an irrigated catheter to achieve block.

In patients with AF, the target of ablation for the "ablate and pace" approach is the compact AV node, located at the apex of the triangle of Koch. Ideally, ablation is performed at the most proximal penetrating part of the His bundle in order to maintain a proximal automatic junctional rhythm and avoid pacemaker dependence.

Para Hisian pacing is most commonly used to reveal the presence of a septal accessory pathway.

The His bundle is a deep insulated structure and it is difficult to capture it at usual energy outputs. Using a high- output pacing (usually 20 mA at 2 msec) it is possible to directly capture the deeply situated His bundle, which is confirmed by a narrower QRS complex on the paced electrograms. Thus, high-output pacing can be utilized to map the His bundle area in difficult situations.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

盲法说明

Variable block sizes will be used to improve the blinding of the clinical team. This information will then be used to design a fully-powered randomized study to compare these two arms. Patients will be randomly assigned to study arms. The project biostatistician and team will generate a set of envelopes which contain the random assignments for each patient. Once a patient has consented to participate, the next envelope will be opened for that patient and the catheter assignment will be revealed. This will maintain the blinding of the clinical team.

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with a diagnosis of persistent or permanent atrial fibrillation documented on electrocardiography
  • Patients must meet American College of Cardiology and Heart Rhythm Society "ACC/HRS" guidelines for atrioventricular nodal ablation procedure
  • Patients must be available for at least 1 month post procedure
  • Patients must be greater than or equal to 18 years old.

排除标准

  • Patients who do not meet ACC/HRS indications for av nodal ablation

结局指标

主要结局

The Time Differences Between the 2 Arms for Acute Success of Ablation Identified by a Junctional Rhythm or Complete Heart Block

时间窗: 60 seconds

Identified by a junctional rhythm or complete heart block. Time zero is when the ablation procedure begins and the successful outcomes are either complete heart block or junctional rhythm.

次要结局

  • Time From Application of Radio-frequency Energy to Acute Success(up to 3000 seconds)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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