跳至主要内容
临床试验/NCT02758002
NCT02758002撤回不适用

Inhibition of Atrial Fibrillation by Elimination of Transitional Mechanisms

University of California, San Diego2 个研究点 分布在 1 个国家开始时间: 2016年1月28日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Changes in AF threshold induction from ablation of transitional rotors

研究概览

简要总结

There is growing awareness of the importance of electrical rotors to the maintenance of atrial fibrillation (AF). Recent work in our laboratory has found that AF evolves over time, from rapid, focal activation, next to transitional rotors, and finally to stable, long duration rotors, whose locations are frequently separate from the transitional rotor sites. This project will test the hypothesis that mapping and ablation of the transitional rotors sites may prevent atrial fibrillation from progressing to sustained atrial fibrillation, and therefore increase the AF initiation threshold. The investigators will test this hypothesis during clinically-indicated electrophysiology study prior to ablation of symptomatic AF.

详细描述

A. Patient Enrollment:

UCSD will enroll subjects with symptomatic AF undergoing clinically-indicated ablation at the Sulpizio Cardiovascular Center.

B. Research Study Data UCSD will record patient demographics (e.g. age, gender, echocardiographic information), AF history (AF duration, previous and current antiarrhythmic medications, prior ablations), medical history (current medication regimen, lab values, etc.), and other relevant history. All recorded digital data such as electrocardiograms and intracardiac recordings will be exported from the recorder stripped of patient identifying information.

C. Electrophysiology (EP) Study and Catheter Placement:

EP study will be performed in the fasting state and after antiarrhythmic medications are discontinued for 5 half-lives (>60 days for amiodarone). Catheters are advanced to the right atrium (RA), coronary sinus, and transseptally to left atrium (LA). A 64-pole basket catheter (FIRMap, Topera, Menlo Park, CA) will map the LA. RA recordings are made using a second basket, simultaneously when possible. Heparin will be infused to maintain activated clotting time >350 seconds.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
21 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with symptomatic atrial fibrillation (AF) undergoing clinically-indicated ablation
  • either persistent or paroxysmal AF

排除标准

  • decompensated heart failure;
  • non-revascularized coronary ischemia
  • LA diameter > 60mm
  • inability or refusal to provide consent

结局指标

主要结局

Changes in AF threshold induction from ablation of transitional rotors

时间窗: 1 day

In patients presenting for AF ablation, the investigator will prospectively determine whether ablation of AF-initiating sites renders AF more difficult to induce, as measured by the rapid pacing cycle length required to initiate AF during two induction attempts consisting of rapid pacing of 15 seconds duration at decreasing cycle lengths.

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 (2)

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