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临床试验/NCT00247351
NCT00247351已完成不适用

Prevention of Atrial Tachycardia After a Right Atriotomy

Aarhus University Hospital Skejby1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2003年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
15
试验地点
1
主要终点
Feasibility of creation of a complete line of block

研究概览

简要总结

We performed a prophylactic peroperative linear 1-minute cryolesion connecting the tricuspid annulus and right atriotomy to prevent IART on 15 consecutive adult patients undergoing surgery for congenital heart disease. Conduction time between electrodes placed on both sides of the cryolesion was measured on the second postoperative day. Coronary angiography and electrophysiology study using an electroanatomic mapping system to assess conduction across the line were performed three month after the operation on 13 patients.

详细描述

Patient selection Consecutive patients operated in the Department of Cardiothoracic Surgery, Aarhus University Hospital at Skejby were included. Inclusion criteria were: 1. Clinical indication for corrective operation for congenital heart disease with the use of a right lateral atriotomy, 2. Age >18 years, 3. Ability to give an informed consent. The only exclusion criterion was acute operation.

Written informed consent was obtained from all the patients prior to the inclusion in the study. The ethical committee for Aarhus County approved the study September 18, 2003.

Operation and postoperative care The operation was performed in the usual fashion. Additionally, a single linear endocardial 1-minute cryolesion connecting the right lateral atriotomy with the tricuspid annulus anteriorly and with crista terminalis posteriorly was performed before the right atriotomy has been sutured (Figure 1). SurgiFrost® cryosurgical probe (Endocare Inc., Irvine, California) was used. Two pairs of epicardial electrodes were placed on the atrium between the incision and the tricuspid annulus 1.5 cm cranially, and caudally from the cryolesion at the end of the repair. They were brought out together to the thorax on the patient's right side. Subsequently, the thorax was closed in the usual way.

Patients were monitored continuously using bedside monitors or telemetry for the first 16-24 hours after the operation. A 12-lead electrocardiogram (ECG) was obtained at any clinical suspicion of arrhythmia. Atrial tachycardia was defined as a sustained regular monomorphic atrial rhythm at a constant rate >100/min originating outside the sinus node.

Measurement of conduction time On the second postoperative day, the conduction time was measured with the help of pacing the electrode pair on the one side of the cryolesion between the incision and the tricuspid annulus and sensing the unipolar signals on the other side (Figure 2). Signals were recorded at 100 mm/s using a commercially available ECG machine.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Prevention
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

入选标准

  • Consecutive patients operated in the Department of Cardiothoracic Surgery, Aarhus University Hospital at Skejby were included. Inclusion criteria were:
  • Clinical indication for corrective operation for congenital heart disease with the use of a right lateral atriotomy,
  • Age >18 years,
  • Ability to give an informed consent.

排除标准

  • Acute operation.

结局指标

主要结局

Feasibility of creation of a complete line of block

Safety

次要结局

未报告次要终点

研究者

发起方
Aarhus University Hospital Skejby
申办方类型
Other

研究点 (1)

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