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临床试验/NCT04148664
NCT04148664已完成不适用

SHORT-AF: A Randomized Trial of High Power-Short Duration Versus Standard Power-Long Duration Radiofrequency Ablation for Treatment of Atrial Fibrillation

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年12月3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
60
试验地点
2
主要终点
Ablation Duration

研究概览

简要总结

This study is a prospective, randomized controlled study to compare overall clinical outcomes between High Power Short Duration (HPSD) and standard radiofrequency (RF) ablation settings for Atrial Fibrillation (AF) ablation in the treatment of subjects with paroxysmal or persistent Atrial Fibrillation.

详细描述

Pulmonary vein isolation using radiofrequency (RF) ablation is a widely used treatment strategy for atrial fibrillation. Peri-procedural complications rates are estimated at between 1.5 - 6% with the two most feared complications being stroke and atrial-esophageal fistula. The risk of these complications increases with (1) longer left atrial dwell times with greater potential for clot formation and (2) esophageal heating during delivery of radiofrequency energy. 'High-power short-duration' (HPSD) is an increasingly utilized strategy to decrease procedure duration and minimize the risk of these complications. Potential mechanisms for benefit include: (1) shorter left atrial dwell times due to more efficient lesion delivery (2) rapid, but more controlled, resistive tissue heating, which avoids deeper, passive conductive heating that can reach the esophagus and cause injury. Moreover, HPSD may improve lesion efficacy and durability due to less recover of excitability after ablation. Despite being widely used and several retrospective studies, there have been no prospective randomized trials comparing outcomes between HPSD and standard RF ablation settings. Moreover, the investigators are interested to see if a shorter procedure (less time in the left atrium) is associated with a lower rate of silent cerebral infarctions (which are occasionally seen on MRI brain post RF ablation - their clinical significance is unclear).

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 (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

  • Male or female ≥18 years of age at their pre-operative visit.
  • Patient is scheduled to have their first AF ablation
  • Paroxysmal or persistent AF
  • Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.

排除标准

  • Prior AF ablation
  • Stroke or transient ischemic attack (TIA) within the previous 6 months
  • Known esophageal ulcer or gastrointestinal (GI) bleed within prior 6 months
  • Intent to perform adjunctive left atrial ablation, including posterior wall isolation, left atrial appendage isolation, mitral or other linear lesions.
  • Prior rheumatic heart disease or significant mitral stenosis
  • Mechanical mitral valve replacement
  • Long lasting persistent AF > 1 year
  • Severe left ventricular systolic dysfunction, with LV ejection fraction LVEF<35%
  • Prior left atrial appendage (LAA) occlusion device
  • Prior septal occlusion device
  • Pacemaker, defibrillator or any contraindication to MRI

结局指标

主要结局

Ablation Duration

时间窗: During Ablation

RF ablation duration from start of first pulmonary vein isolation lesion to end of last lesion

次要结局

  • Pericardial tamponade requiring drainage(During ablation or up to 30 days post ablation)
  • Total left atrial radiofrequency (RF) time(During Ablation)
  • Freedom from Atrial Fibrillation(assessed at 6 and 12 months post-ablation)
  • Total saline infused(During Ablation)
  • Maximum esophageal temperature rise(During ablation)
  • % pulmonary vein pairs isolated with first encirclement(During Ablation)
  • Maximum esophageal temperature(During ablation)
  • Total procedure duration(During Ablation)
  • Number of radiofrequency lesions required for isolation/PV(During Ablation)
  • Overall complication rate(During Ablation and up to 12 month follow up assessment)
  • Pleurisy(At 1 week and 1 month assessment)
  • Pericardial effusion>1cm(During ablation or up to 30 days post ablation)
  • Presence of asymptomatic cerebral emboli(1 day post-ablation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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