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临床试验/NCT02493075
NCT02493075Unknown1 期

Ablation of Paroxysmal Atrial Fibrillation Using the Appropriate Contact Force in a Chinese Population: A Prospective Randomized Single-center Trial

Sir Run Run Shaw Hospital1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
1 期
入组人数
140
试验地点
1
主要终点
Atrial fibrillation (AF) recurrence rate

研究概览

简要总结

The objective of the study is:Phase I: To validate or otherwise determine the Chinese-specific appropriate contact force during PVI in PAF.Phase II: To evaluate the effectiveness and safety of ablation guided by the appropriate contact force.

详细描述

Background: Atrial fibrillation (AF) is a major cause of substantial mortality and morbidity from thromboembolism, heart failure (HF), and cognitive dysfunction. With the aging of the population and improved survival after myocardial infarction and HF, AF is emerging as a major public health concern.

Recently, significant progress has been made in treatment of AF with catheter ablation, emerging as an increasingly important technique. According to the current guidelines, catheter ablation can be considered as the first-line treatment of choice for patients with drug refractory paroxysmal AF (PAF). Circumferential PV isolation (CPVI) is a widely accepted cornerstone of this procedure, but limited by an unacceptable recurrence rate, mainly due to recovery of pulmonary vein (PV) conduction.

Durable, continuous, transmural isolation of PV is one of the most important goals of radiofrequency catheter ablation (RFCA) for PAF. The contact force (CF) between the ablation catheter and target tissue was considered closely related to the ablation effectiveness. Appropriate CF should be able to generate enough tissue lesions, and avoid the complications, such as cardiac perforation, atrial-esophageal fistula. Nowadays, irrigated ablation catheters are widely used, but the CF is mostly dependent on operators' experience and feeling, unable to be precisely measured. The tissue lesion produced would be variable in different operators, and the learning curve would be time consuming.

The newly approved CF catheter enables measurement of catheter tip contact force and force vector, providing the real-time CF during ablation. It would be helpful, not only for effective lesions formation, but also for the prevention from complications.

Studies from Western-population indicated that higher long-term successful rate could be achieved by using CF catheter, and CF between 10 to 20g was adopted in most centers. It would be important to find the appropriate range of CF for Chinese populations, because of various factors including for instance thinner and smaller atrial chambers among Chinese.

研究设计

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

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 18 - 75 years
  • Symptomatic PAF refractory to at least one antiarrhythmic drug
  • Minimum of two episodes of recurrent self-terminating AF within prior 12 months and with latest documented episode within 6 months prior ablation procedure
  • First catheter ablation
  • Patient is able and willing to provide written informed consent.

排除标准

  • Persistent or long-standing persistent AF
  • >4 cardioversions in prior 12 months
  • Myocardial infarction(MI), coronary artery bypass grafting(CABG) or percutaneous coronary intervention (PCI) within preceding 3 months
  • Left atrial diameter >5.0 cm or <3.5 cm
  • Left ventricular ejection fraction by echocardiography <40%
  • New York Heart Association(NYHA)class III or IV
  • History of heart surgery or any previous ablation for AF
  • Intracardiac thrombus
  • Females who are pregnant or breast feeding.

结局指标

主要结局

Atrial fibrillation (AF) recurrence rate

时间窗: one year

Patients will be followed up at 1, 3, 6, 9, 12months post ablation. Patients' experiences, 12-lead electrocardiograms (ECGs) and Holter monitoring (non-required at 1, 9 months) will be recorded to evaluate recurrence at each appointment (not including 1 and 3 month visit post procedure) and any visits when the patient experience symptoms that suggestive of arrhythmia. The first 3 months is considered as a blanking period.Recurrence is defined as AF/flutter/tachycardia, lasting longer than 30s, that documented by an ECG or Holter recording, or highly suggestive symptoms, after 3 months post-procedure.

次要结局

  • Time Data related with procedure(intraoperative)
  • Number of participants with Mortality and complications(one year)

研究者

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

Chenyang Jiang

chief physician

Sir Run Run Shaw Hospital

研究点 (1)

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