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Paroxysmal Atrial Fibrillation Repeat Ablation Strategies With Durably Isolated Pulmonary Veins (PARADISO)

2026年11月2日 更新者：Ottawa Heart Institute Research Corporation

Paroxysmal Atrial Fibrillation Repeat Ablation Strategies With Durably Isolated Pulmonary Veins (PARADISO): a Vanguard Study

This study looks at participants who have undergone an ablation procedure for atrial fibrillation previously, and atrial fibrillation has occurred and a second ablation procedure is needed. The study will randomize participants to either a tailored strategy for ablation or to widening the pulmonary vein isolation procedure with or without cavotricuspid isthmus ablation. The goal is to improve freedom from recurrent atrial arrhythmias at 12 months.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

This is a study of patients who have undergone an ablation procedure for AF but in whom AF recurred and who are undergoing a second ablation procedure. Specifically, the investigators are interested in the group of patients whose PVs are still "isolated" during that second procedure because doctors are unsure of how best to ablate them. It is even possible that doing any more ablation in those patients is harmful.

The study will compare (1) an ablation strategy that includes commonly done ablation steps that tackle abnormalities found during the procedure (i.e., ablating "low voltage areas", searching for and ablating other arrhythmias called supraventricular tachycardias, and in some patients ablating the "posterior wall") to (2) an ablation strategy that reinforces or extends the PVI step only. In both groups, cavotricuspid isthmus ablation is also performed, if not already successfully done previously. The vanguard study will follow participants for 1 year, with a 3 year follow up planned if feasibility is met. Participants will be required to wear a Holter monitor at various timepoints and will be asked to complete atrial fibrillation and quality of life questionnaires.

研究类型

介入性

注册 (估计的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 加拿大
    • Ontario
      • Ottawa、Ontario、加拿大、K1Y 4W7
        • University of Ottawa Heart Institute
        • 副研究员：
          • David Birnie, MD
        • 接触：
        • 首席研究员：
          • F. Daniel Ramirez, MD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Paroxysmal atrial fibrillation with durable pulmonary vein isolation (PVI)
  • Age >/= 18 years
  • at least one episode of atrial fibrillation documented on 12-lead ECG, Holter monitor, or loop recorder in the preceding 12 months
  • ability to provide informed consent

Exclusion Criteria:

  • Persistent atrial fibrillation
  • documented sustained atrial tachycardia or atypical atrial flutter.
  • Previous atrial ablation excluding PVI or cavotricuspid Isthmus (CTI) ablation (having undergoing more than one procedure is acceptable as long as only PVI +/- CTI ablation was preformed)
  • previous left atrial surgery
  • known PV stenosis or history of PV intervention
  • active intracardiac thrombus
  • contraindication to systemic anticoagulation
  • hypertrophic cardiomyopathy
  • significant left-sided valve disease (moderate or severe mitral or aortic stenosis or regurgitation)
  • significant congenital heart disease, including atrial septal defects or PV abnormalities (patent foramen ovale is not an exclusion)
  • active pregnancy
  • participation or anticipated participation in another clinical trial that could affect the results of this trial
  • unwillingness or inability to adhere fully with study procedures and follow up

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Tailored Strategy

Homogenizing left atrium/atrial (LA) low voltage areas (LVAs), ablating inducible supraventricular tachycardia (SVTs), and if no abnormality is identified, performing empiric posterior wall isolation (PWI )followed by cavotricuspid isthmus (CTI) ablation (if successful CTI ablation not performed previously).
程序：Tailored Strategy

Homogenizing left atrium/atrial (LA) low voltage areas (LVAs), ablating inducible supraventricular tachycardia (SVTs), and if no abnormality is identified, performing empiric posterior wall isolation (PWI )followed by cavotricuspid isthmus (CTI) ablation (if successful CTI ablation not performed previously).
其他：Control Strategy

Widening wide area circumferential ablation (WACA) lines and cavotricuspid isthmus (CTI) ablation if not successfully performed previously.
程序：Control Strategy

Widening wide area circumferential ablation (WACA) lines and cavotricuspid isthmus (CTI) ablation if not successfully performed previously.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Freedom from recurrent atrial arrhythmia lasting >/= 30 seconds
大体时间：Days 57 to 365 from repeat procedure.

Atrial arrhythmias include atrial fibrillation, atrial flutter, or atrial tachycardia.
Days 57 to 365 from repeat procedure.

次要结果测量

结果测量
措施说明
大体时间
Procedure duration
大体时间：From beginning of vascular access to removal of all catheters

Time, in minutes, of the repeat procedure
From beginning of vascular access to removal of all catheters
Composite of major procedure-related complications
大体时间：Baseline to 12 months

Procedure-related complications include embolic events, pulmonary vein stenosis, cardiac perforation, major bleeding, atrioesophageal fistula, or death)
Baseline to 12 months
Emergency Room visits or re-hospitalizations
大体时间：Baseline to 12 months

Visits and admissions related to recurrent atrial arrhythmias
Baseline to 12 months
Repeat Catheter Ablation procedure
大体时间：Baseline to 12 months

Occurrence of additional ablation after the study index procedure.
Baseline to 12 months
Atrial Fibrillation Effect on Quality of Life
大体时间：Baseline to 12 months.

Measured by the Atrial Fibrillation Effect on Quality of Life questionnaire. Scale of 0-100, with 100 being best quality of life.
Baseline to 12 months.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Ottawa Heart Institute Research Corporation

调查人员

  • 首席研究员：F. Daniel Ramirez, MD、Ottawa Heart Institute Research Corporation

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年12月1日

初级完成 (估计的)

2030年9月1日

研究完成 (估计的)

2032年9月1日

研究注册日期

首次提交

2026年10月13日

首先提交符合 QC 标准的

2026年10月27日

首次发布 (实际的)

2026年11月2日

研究记录更新

最后更新发布 (实际的)

2026年11月3日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 20260577-01H

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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