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临床试验/NCT02664311
NCT02664311终止不适用

A Randomized Comparison of the Use of JET and Conventional Ventilation in Pulmonary Vein Isolation

Beth Israel Deaconess Medical Center1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2013年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
21
试验地点
1
主要终点
Isolation Time

研究概览

简要总结

This is a randomized prospective study comparing outcomes of pulmonary vein isolation using conventional and jet ventilation.

详细描述

Atrial fibrillation (AF) is the most common cardiac arrhythmia in the United States today. Its incidence increases with age, and the prevalence approaches 10% in patients over 80 years old. Atrial fibrillation increases the risk of strokes, and in some patients is associated with worsened congestive heart failure and quality of life.

Catheter based radiofrequency ablation for atrial fibrillation is an evolving and promising technology, and provides increased freedom from AF and improved quality of life compared with pharmacologic therapy. The technique involves placing catheters through the femoral veins into the heart, including the left atrium. Access to the left atrium is performed by transseptal puncture. Ablation of atrial fibrillation is performed by delivery of radiofrequency energy around the pulmonary veins in order to electrically dissociate them from the atria. This is thought to eliminate common triggers for atrial fibrillation, and therefore reduces the recurrence of AF in some patients.

The ablation procedure is done under general anesthesia and takes 4-8 hours. The first part of the procedure involves creating a computer generated three dimensional model of the left atrium. Once this model is created any patient movement will disrupt its accuracy and interfere with the physician's ability to accurately locate the catheter within the atrium.

The success of AF ablation is dependent upon the creation of an accurate three dimensional model, as well as physicians ability to perform durable lesions and achieve effective isolation of the pulmonary veins. Among the barriers to technical success are the patient's respiratory movement, which impairs catheter stability and the ability to maintain a stable catheter position against the atrium of the heart during ablation. Thus, minimizing respiratory movement during the procedure is critical to procedural outcome.

High frequency jet ventilation (HFJV) is a newer mode of ventilation that relies on very small tidal volumes delivered at high frequency (approximately 80-120 breaths/minute). Initially developed in the critical care setting, HFJV produces less respiratory motion due the small tidal volumes delivered. HFJV has been used successfully in procedures requiring increased stability of the field of interest, such as lithotripsy and percutaneous hepatic and renal radiofrequency ablation as well as stereotactic high single-dose irradiation of stage I non-small cell lung cancer and lung metastases. The initial report of the use of HFJV in radiofrequency catheter ablation (RFCA) of atrial fibrillation was by Goode et al in 2006. In that retrospective analysis, the use of HFJV was associated with a decrease in the number of ablation lesions, due to decreased number of attempts aborted by catheter dislodgement, as well as decreased variation in the size of the left atrium (LA) due to changes in pulmonary pressures associated with conventional ventilation. The incidence of complications was not significantly different between the HFJV and conventionally ventilated patients. More recently, Elkassabany et al. retrospectively reviewed their institutional experience with Jet ventilation, and found that the procedure could be performed safely.

研究设计

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

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •paroxysmal or persistent AF, first time PVI or left atrial procedure

排除标准

  • •repeat procedure
  • •any contraindications to receiving JET ventilation in the judgement of the treating anesthesiologist

研究组 & 干预措施

Conventional Ventilation

Placebo Comparator

Patients receiving conventional ventilation for the duration of this study

干预措施: Conventional ventilation (Device)

Jet Ventilation

Active Comparator

Patients receiving Jet ventilation while under general anesthesia and during mapping and ablation in the left atrium

干预措施: Jet Ventilation (Device)

结局指标

主要结局

Isolation Time

时间窗: Immediate post procedure

Comparison of Time (in Minutes) From Obtaining Access to Left Atrium Via Transseptal Catheterization to Demonstrated Isolation of All Pulmonary Veins - hypothesis is that with Jet ventilation there will be a shorter time to pulmonary vein isolation in comparison to conventional ventilation

次要结局

  • Freedom From AF(1 year)
  • Fluoroscopy Time(Immediate post-procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alfred Buxton

Principal Investigator

Beth Israel Deaconess Medical Center

研究点 (1)

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