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临床试验/NCT06249347
NCT06249347招募中不适用

Pulmonary Vein Isolation and Left Roof Linear, Mitral Isthmus Linear, and Left Anterior Septal Linear Ablation, and Left Atrial Appendage Device Occlusion in Patients With Non-paroxysmal Atrial Fibrillation: PROMISED Trial.

Second Affiliated Hospital of Wenzhou Medical University1 个研究点 分布在 1 个国家目标入组 166 人开始时间: 2024年1月28日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
166
试验地点
1
主要终点
Recurrence of atrial arrhythmia after a single ablation procedure.

研究概览

简要总结

The purpose of this prospective randomized study is to assess whether a new treatment strategy consisting of circumferential Pulmonary vein isolation (PVI), left ROof linear (RL), Mitral Isthmus linear (MIL), and left anterior SEptal linear (ASL) ablation and left atrial appendage (LAA) Device occlusion (PROMISED procedure) is superior to the PVI combined LAA closure in enhancing the long-term success rate of catheter ablation in non-paroxysmal atrial fibrillation (AF) patients.

详细描述

Circumferential pulmonary vein isolation (CPVI) is an important radiofrequency catheter ablation strategy for AF. The recurrence rate of non-paroxysmal AF (non-PAF) after CPVI remains unsatisfactory, despite the use of additional strategies, such as linear ablation and complex fractionated atrial electrogram ablation. Non-PAF initiation and maintenance depend on a critical mass, which allows reentry. The left atrial anterior wall contains a series of substrates that are associated with AF, such as low-voltage zones, Bachmann's bundle, and the LAA, which are important for AF initiation and maintenance. Combining CPVI with left RL, left ASL, and MIL ablation can create a box lesion set on the anterior wall which compartmentalize the left atrial anterior wall into small regions to modify the substrate. We hypothesized that this substrate modification strategy would improve the success rate of non-PAF ablation. However, functional damage to the LAA resulting from the above-mentioned ablation strategy may increase stroke risk. The combined use of AF ablation and LAA occlusion is safe and can reduce stroke risk. Therefore, we examined the safety, feasibility, and efficacy of a new treatment strategy for non-PAF, defined as the CPVI; left ROof linear, Mitral Isthmus linear, and left anterior SEptal linear ablation; and LAA Device occlusion (PROMISED) procedure. Cases were prospectively treated in a 2-arm 1:1 design according to ablation strategy, divided into the Promised group (n = 83) or the PVI combined LAAC group (n =83).

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

  • Age > 18 years;
  • Persistent AF (AF duration > 7 days);
  • CHA2DS2-VASc score ≥2;
  • Presence of at least one of the following conditions:
  • Unsuitable for long-term standardized anticoagulation therapy;
  • Stroke or embolism still occurred based on long-term standardized anticoagulation therapy;
  • HAS-BLED score ≥3;
  • Unwillingness for long-term anticoagulation therapy;

排除标准

  • Previous atrial fibrillation ablation
  • Transthoracic echocardiography suggests that the anteroposterior diameter of the left atrium is greater than 60 mm;
  • persistent AF that lasts >10 years
  • Scheduled cardiac surgical intervention.
  • Documented left atrial thrombus/ left atrial appendage thrombus or another abnormality that precludes catheter/LAAC introduction
  • Life expectancy less than 1 year

结局指标

主要结局

Recurrence of atrial arrhythmia after a single ablation procedure.

时间窗: 12 months after the first procedure

Recurrence rate (percentage) of atrial fibrillation or atrial flutter or atrial tachycardia \> 30 seconds after the blanking period of 3-month post ablation, at 1 year after a single ablation procedure. (use of antiarrhythmic medications was not allowed after the blanking period of 3-month)

次要结局

  • Occurrence of Intra-procedure conversion of persistent AF to sinus rhythm rate and Its Relationship to 1-Year Sinus Rhythm Maintenance Rate(12 months after the first procedure)
  • Recurrence of AF after a single ablation procedure(12 months after the first procedure)
  • Recurrence of atrial flutter/atrial tachycardia after a single ablation(12 months after the first procedure)
  • Occurrence of Intra-procedure Conversion from AF to Atrial Flutter or Atrial Tachycardia rate and Its Relationship to 1-Year Sinus Rhythm Maintenance Rate(12 months after the first procedure)
  • Incidence of periprocedural complications(period of Post-operative to hospital discharge)
  • Incidence of events including device-related thrombus and peri-device leak at 3 months post-procedure(3 months after the first procedure)
  • post-procedure complications(12 months after the first procedure)
  • Procedure duration of three-dimensional reconstruction of the left atrial(At the end of the first procedure)
  • Procedure duration at ablation(At the end of the first procedure)
  • Procedure duration at LAAC(At the end of the first procedure)
  • Anticoagulant discontinuation rate at 6 months post-procedure(6 months after the first procedure)

研究者

发起方
Second Affiliated Hospital of Wenzhou Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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