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临床试验/NCT02766712
NCT02766712已完成不适用

The Physiological Effects of Pacing on Catheter Ablation Procedures to Treat Atrial Fibrillation

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
1
主要终点
Percentage of time spent above CF 10 grams between paced and non-paced lesions at Left superior pulmonary vein

研究概览

简要总结

This is a two arm randomized, paired prospective study comparing the percentage of time spent above Contact Force (CF), Force Time Integral (FTI) and other lesion parameters in the setting of pacing versus non-pacing. This study is designed to compare the percentage of time spent above CF 10 grams between paced and non-paced lesions at 15 pre-determined lesion locations.

详细描述

Patients will be randomized and proceed to one of two study arms:

  1. Pacing during first half of lesions: During each of the 15 pre-specified lesions, pacing will be initiated at a 500ms cycle length from a catheter in the coronary sinus or right ventricle prior to the start of the lesion. Pacing will be stopped at the halfway point (e.g. after 10 seconds for a 20-second lesion and after 15 seconds for a 30-second lesion). In the event that Wenckebach behavior is noted, pacing will be adjusted to a 550ms cycle length. In the event that Wenckebach behavior persists, the cycle length will be adjusted to 600ms. In the event that Weckebach behavior continues, the pacing catheter will be moved to the right ventricle, which and pacing will be performed at a 500ms cycle length. If Wenckebach behavior still persists, the patient will be withdrawn from the study.
  2. Pacing during second half of lesions: During each of the 15 pre-specified lesions, pacing will be stopped at the halfway point (e.g. after 10 seconds for a 20-second lesion and after 15 seconds for a 30-second lesion). In the event that Wenckebach behavior is noted, pacing will be adjusted to a 550ms cycle length. In the event that Wenckebach behavior persists, the cycle length will be adjusted to 600ms. In the event that Wenckebach behavior persists, the pacing catheter will be moved to the right ventricle and pacing will be performed at a 500ms cycle length. If Wenckebach behavior still persists, the patient will be withdrawn from the study.

研究设计

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

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

  • Patients with AF scheduled for AF ablation with planned pulmonary vein isolation
  • Presenting in normal sinus rhythm (NSR) prior to lesion delivery

排除标准

  • Previous radiofrequency ablation
  • Previous thoracotomy-type AF ablation (MAZE or similar technique)
  • In AF prior to lesion delivery
  • Evidence of left atrial scarring on voltage map
  • Resting heart rate > 90 bpm

结局指标

主要结局

Percentage of time spent above CF 10 grams between paced and non-paced lesions at Left superior pulmonary vein

时间窗: 30 Seconds

Percentage of time spent above CF 10 grams between paced and non-paced lesions at Right inferior pulmonary vein

时间窗: 30 Seconds

Percentage of time spent above CF 10 grams between paced and non-paced lesions at Anterior CTI

时间窗: 30 Seconds

Percentage of time spent above CF 10 grams between paced and non-paced lesions at Right middle pulmonary vein

时间窗: 20 Seconds

Percentage of time spent above CF 10 grams between paced and non-paced lesions at Left pulmonary vein carina

时间窗: 30 Seconds

Percentage of time spent above CF 10 grams between paced and non-paced lesions at Left middle pulmonary vein

时间窗: 20 Seconds

Percentage of time spent above CF 10 grams between paced and non-paced lesions at Left inferior pulmonary vein

时间窗: 30 Seconds

Percentage of time spent above CF 10 grams between paced and non-paced lesions at Right superior pulmonary

时间窗: 30 Seconds

Percentage of time spent above CF 10 grams between paced and non-paced lesions at Right pulmonary vein carina

时间窗: 30 Seconds

Percentage of time spent above CF 10 grams between paced and non-paced lesions at Middle CTI

时间窗: 30 Seconds

Percentage of time spent above CF 10 grams between paced and non-paced lesions at Posterior CTI

时间窗: 30 Seconds

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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