此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Efficacy, Safety and Efficiency Study of CARTO® 3 System Guided THERMOCOOL® Catheter Ablation Versus Fluoroscopy Guided Ablation With the Pulmonary Vein Ablation Catheter® (PVAC®) (CLARITY-AF)

2014年10月1日 更新者：Biosense Webster, Inc.

CARTO® 3 System-guided RF Ablation Using the THERMOCOOL® Catheter Versus Fluoroscopy-guided RF Ablation Using the Pulmonary Vein Ablation Catheter® (PVAC®) in Subjects With Paroxysmal Atrial Fibrillation: A Prospective, Multi-center, Randomized (2:1), Controlled, Two-arm, Unblinded Clinical Study

The purpose of this study is to compare the efficacy, safety and efficiency of CARTO® 3 system guided THERMOCOOL® catheter ablation and fluoroscopy guided Pulmonary Vein Ablation Catheter® (PVAC®) guided ablation for the treatment of paroxysmal atrial fibrillation.

研究概览

地位

终止

条件

干预/治疗

详细说明

This study is a prospective, multi-center, randomized (2:1), controlled, two-arm, unblinded, clinical study, which will evaluate the efficacy, safety, and efficiency of CARTO® 3 System-guided RF ablation (using the THERMOCOOL® Catheter and LASSO® Circular Mapping Catheter) compared to fluoroscopy-guided RF ablation (using the PVAC®). Patients with symptomatic PAF who meet the inclusion criteria will be considered for study participation and may be enrolled if no exclusion criteria apply.

Eligible subjects who signed the study informed consent form will be randomized into one of two treatment groups:

  • THERMOCOOL® Group: RF ablation to achieve PVI using the CARTO® 3 System, THERMOCOOL® Catheter and LASSO® Circular Mapping Catheter
  • PVAC® Group: RF ablation to achieve PVI using fluoroscopy and the PVAC®

研究类型

介入性

注册 (实际的)

79

阶段

  • 第四阶段

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。

学习地点

  • 丹麦
      • Värde、丹麦、6800
        • Heart Center Varde
  • 加拿大
      • Ontario、加拿大、L3Y 2P9
        • Southlake Regional Health Centre
    • Ontario
      • Newmarket、Ontario、加拿大、L3Y2P9
        • Southlake Regional Health Centre
  • 德国
      • Köln、德国、51149
        • Krankenhaus Porz Cologne
  • 比利时
      • Antwerpen、比利时、2020
        • A.Z. Middelheim
      • Brugge、比利时、8000
        • A.Z. St Jan AV
  • 英国
    • Essex
      • Basildon、Essex、英国、SS16 5NL
        • Essex Cardiothoracic Centre
  • 荷兰
      • Eindhoven、荷兰、5623 EJ
        • Catharina Ziekenhuis
      • Zwolle、荷兰、8011
        • Isala Klinieken

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:

  • Patients with PAF who have had two (2) symptomatic PAF episodes in the six (6) months prior to randomization, and who are selected for catheter ablation for the treatment of their AF. Additionally patients with recurrent AF with episodes up to 30 days with sinus rhythm maintained for more than one week following cardioversion and who require PVI only for the treatment of their AF (supported by the consensus statement2). At least one AF episode should be documented either on ECG, TTM, HM or telemetry strip.
  • Failure of at least one AAD for PAF [class I or III] as evidenced by recurrent symptomatic PAF, or intolerable side effects due to the AAD.
  • Signed Patient Informed Consent Form.
  • Age 18 years or older.
  • Able and willing to comply with all pre- and follow-up testing and requirements.

Exclusion Criteria:

  • Longstanding persistent atrial fibrillation
  • Patients with a history of any atrial flutter requiring ablation in the right atrium during the study procedure
  • Patients in whom sinus rhythm was maintained for less than 1 week after electrical cardioversion
  • Previous ablation for AF
  • LA size > 55 mm
  • LVEF < 40% (ejection fraction)
  • AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
  • CABG procedure within the last six (6) months
  • Awaiting cardiac transplantation or other cardiac surgery
  • Documented left atrial thrombus on imaging (eg, TEE)
  • Diagnosed atrial myxoma
  • Women who are pregnant (by history of menstrual period or pregnancy test if the history is considered unreliable) or breastfeeding
  • Acute illness or active systemic infection or sepsis
  • Unstable angina
  • Uncontrolled heart failure
  • Myocardial infarction within the previous two (2) months
  • History of blood clotting or bleeding abnormalities
  • Contraindication to anticoagulation therapy (ie. heparin or warfarin)
  • Life expectancy less than 12 months
  • Enrollment in any other study evaluating another device or drug
  • Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation

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：阶乘赋值
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
其他：THERMOCOOL® group
Radiofrequency ablation to achieve PVI using the CARTO® 3 System, the THERMOCOOL® Catheter and the LASSO® Circular Mapping Catheter.
设备：Radiofrequency Ablation procedure
Radiofrequency Ablation procedure Application of radiofrequency energy with the THERMOCOOL® catheter used in combination with the CARTO® 3 System and the LASSO® Circular Mapping Catheter to eliminate potentials arising from the pulmonary veins.
其他名称：
  • CARTO®3 System
  • LASSO® Circular Mapping Catheter
  • THERMOCOOL® Catheter
设备：Radiofrequency Ablation procedure
Application of radiofrequency energy with the Pulmonary Vein Ablation Catheter® (PVAC®) to eliminate potentials arising from the pulmonary veins.
其他名称：
  • PVAC®
有源比较器：PVAC® group
Radiofrequency ablation to achieve PVI using fluoroscopy and the PVAC®
设备：Radiofrequency Ablation procedure
Radiofrequency Ablation procedure Application of radiofrequency energy with the THERMOCOOL® catheter used in combination with the CARTO® 3 System and the LASSO® Circular Mapping Catheter to eliminate potentials arising from the pulmonary veins.
其他名称：
  • CARTO®3 System
  • LASSO® Circular Mapping Catheter
  • THERMOCOOL® Catheter
设备：Radiofrequency Ablation procedure
Application of radiofrequency energy with the Pulmonary Vein Ablation Catheter® (PVAC®) to eliminate potentials arising from the pulmonary veins.
其他名称：
  • PVAC®

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 documented AF/AT recurrences without new AADs
大体时间：1 year follow-up post-ablation
Subjects will be considered a success for the primary efficacy endpoint if the subject is free from documented recurrences of AF or AT lasting more than 30s as measured with Transtelephonic Monitoring and Standard of Care arrhythmia monitoring during a 3-12 month follow-up period post-ablation.
1 year follow-up post-ablation
Incidence of PV Stenosis (number of PVs with a reduction in diameter ≥ 50% at 6 months compared to baseline per CT or MRI)
大体时间：at 6 months post-ablation
at 6 months post-ablation
Total procedure time
大体时间：at the time of the initial ablation procedure
at the time of the initial ablation procedure

次要结果测量

结果测量
措施说明
大体时间
Acute procedural success
大体时间：at the time of the initial ablation procedure
Measured by the number (%) of subjects with confirmed entrance block at the end of the ablation procedure
at the time of the initial ablation procedure
Repeat ablation procedures for AF/AT recurrences
大体时间：through 3-12 month follow-up period post-ablation
Measured by % of subjects undergoing repeat ablation procedures for Recurring AF/AT
through 3-12 month follow-up period post-ablation
Freedom from documented AF/AT recurrences without AAD(s)
大体时间：through 3-12 month follow-up period post-ablation
Measured by % achieving freedom from documented AF/AT recurrences
through 3-12 month follow-up period post-ablation
Freedom from documented AF/AT recurrences with AAD(s)
大体时间：through 3-12 month follow-up period post-ablation
Measured by % achieving freedom from documented AF/AT recurrences
through 3-12 month follow-up period post-ablation
Freedom from documented AF/AT recurrences after more than one ablation procedure
大体时间：through 3-12 month follow-up period post-ablation
Measured by % achieving freedom from documented AF/AT recurrences
through 3-12 month follow-up period post-ablation
Freedom from documented AF recurrences without AADs
大体时间：through 3-12 month follow-up period post-ablation
Measured by % achieving freedom from documented AF/AT recurrences
through 3-12 month follow-up period post-ablation
Freedom from documented AF recurrences with AAD(s)
大体时间：through 3-12 month follow-up period post-ablation
Measured by % achieving freedom from documented AF/AT recurrences
through 3-12 month follow-up period post-ablation
Freedom from documented symptomatic AF/AT recurrences without new AAD(s)
大体时间：through 3-12 month follow-up period post-ablation
Measured by % achieving freedom from documented symptomatic AF/AT recurrences
through 3-12 month follow-up period post-ablation
Freedom from documented symptomatic AF/AT recurrences with AAD(s)
大体时间：through 3-12 month follow-up period post-ablation
through 3-12 month follow-up period post-ablation
Incidence of any procedure-related and/or device-related adverse events occurring during the study
大体时间：through 1 year follow-up
through 1 year follow-up
Incidence of any catheter-related adverse events
大体时间：during 7 days follow-up post-ablation
during 7 days follow-up post-ablation
Total Fluoroscopy exposure time
大体时间：at the time of the ablation procedure
Measured by fluoroscopy and cine-fluoroscopy time throughout procedure
at the time of the ablation procedure
Total Fluoroscopy Dose-Area Product/Source Intensifier Distance
大体时间：at the time of the ablation procedure
at the time of the ablation procedure
Incidence of any phrenic nerve paralysis
大体时间：through 1 year follow-up post-ablation
through 1 year follow-up post-ablation
Incidence of any symptomatic Transient Ischemic Attack (TIA) or Cerebrovascular Accident (CVA)
大体时间：through 1 year follow-up post-ablation
through 1 year follow-up post-ablation
Number of mapping and ablation catheters used per subject
大体时间：through 1 year follow-up post-ablation
through 1 year follow-up post-ablation
Quality of Life (SF-36®) and Atrial Fibrillation Symptom Frequency and Severity Checklist assessment
大体时间：Baseline, 3, 6 and 12 months
Baseline, 3, 6 and 12 months
Total procedure hospital visit and ablation procedure costs
大体时间：during hospitalization stay for study treatment
during hospitalization stay for study treatment
Total number of initial or prolonged hospitalizations and unscheduled arrhythmia-related health care provider visits (including emergency department visits)
大体时间：through 1 year follow-up post-ablation
through 1 year follow-up post-ablation

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

Biosense Webster, Inc.

调查人员

  • 首席研究员：Mattias Duytschaever, MD、A.Z. St Jan AV
  • 首席研究员：Yves De Greef, MD、A.Z. Middelheim
  • 首席研究员：Stuart Harris, MD、Essex Cardiothoracic Centre
  • 首席研究员：Peter Steen Hansen, MD、Heart Center Varde
  • 首席研究员：Pepijn Van Der Voort, MD、Catharina Ziekenhuis
  • 首席研究员：Thomas Deneke, MD、Krankenhaus Porz Cologne
  • 首席研究员：Arif Elvan, MD、Isala
  • 首席研究员：Yaariv Khaykin, MD、Southlake Regional Health Centre

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

2010年4月1日

初级完成 (实际的)

2011年12月1日

研究完成 (实际的)

2011年12月1日

研究注册日期

首次提交

2010年5月3日

首先提交符合 QC 标准的

2010年5月4日

首次发布 (估计)

2010年5月5日

研究记录更新

最后更新发布 (估计)

2014年10月2日

上次提交的符合 QC 标准的更新

2014年10月1日

最后验证

2014年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • BWI130

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.

Radiofrequency Ablation procedure的临床试验

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Chile

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
订阅