[未经美国 FDA 批准或许可的设备的试用] (SMARTPULSE PAF)
2026年1月15日 更新者：Biosense Webster, Inc.
本研究的目的是证明 Biosense Webster (BWI) 消融系统（THERMOCOOL SMARTTOUCH 环绕流 [STSF] 导管和 TRUPULSE 发生器）在用于隔离心房肺静脉 (PV) 治疗参与者时的安全性和有效性阵发性心房颤动 (PAF)，一种导致血流异常的心率不齐。
研究概览
研究类型
介入性
注册 (实际的)
237
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。
学习地点
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Alabama
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Birmingham、Alabama、美国、35294
- University of Alabama at Birmingham
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Birmingham、Alabama、美国、35243
- Grandview Medical Center
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California
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Los Angeles、California、美国、90033
- Keck School of Medicine of USC
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Florida
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Atlantis、Florida、美国、33462
- HCA Florida JFK Hospital
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Jacksonville、Florida、美国、32204
- Ascension St. Vincent's
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Miami、Florida、美国、33133
- HCA Florida Mercy Hospital
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Sarasota、Florida、美国、34239
- Sarasota Memorial Hospital
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Georgia
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Macon、Georgia、美国、31201
- Georgia Arrhythmia Consultants and Research Institute
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Savannah、Georgia、美国、31404
- Memorial Health University Medical Center
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Illinois
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Chicago、Illinois、美国、60612
- Rush University Medical Center
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Maywood、Illinois、美国、60153
- Loyola University Medical Center
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Kansas
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Kansas City、Kansas、美国、66160
- University of Kansas Medical Center
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Overland Park、Kansas、美国、66211
- The Kansas City Heart Rhythm Institute
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Kentucky
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Lexington、Kentucky、美国、40503
- Baptist Health Lexington
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Louisville、Kentucky、美国、40205
- Norton Heart Specialist
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Massachusetts
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Boston、Massachusetts、美国、02114
- Massachusetts General
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Michigan
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Ypsilanti、Michigan、美国、48197
- Trinity Health Michigan Heart - Ann Arbor Campus
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New Jersey
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Haddon Heights、New Jersey、美国、08035
- Cardiovascular Associates of the Delaware Valley
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New York
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New York、New York、美国、10016
- NYU Langone Health
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The Bronx、New York、美国、10467
- Montefiore Medical Center
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North Carolina
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Winston-Salem、North Carolina、美国、27157
- Wake Forest Baptist Medical Center
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Ohio
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Cleveland、Ohio、美国、44106
- University Hospitals Cleveland Medical Center
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Columbus、Ohio、美国、43210
- Ohio State University
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Columbus、Ohio、美国、43214
- Ohio Health Research Institute
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South Carolina
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North Charleston、South Carolina、美国、29406
- Trident Medical Center
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Texas
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Austin、Texas、美国、78705
- Texas Cardiac Arrhythmia Research Foundation
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Plano、Texas、美国、75093
- Baylor Scott & White Research Institute at The Heart Hospital Baylor Plano
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San Antonio、Texas、美国、78201
- Methodist Texsan
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Virginia
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Norfolk、Virginia、美国、23507
- Sentara Norfolk General Hospital
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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
- 成人
- 年长者
接受健康志愿者
不
描述
纳入标准：
- 诊断为有症状的阵发性心房颤动 (PAF)，且 (a) 在入组后的最后六个月内至少发生过两次有症状的心房颤动 (AF) 发作，并且 (b) 通过心电图 (ECG) 记录至少有一次 AF 发作；入组前 12 个月内进行电话转接监测 (TTM)、动态心电图监测仪、遥测带或植入设备
- 至少一种抗心律失常药物 (AAD)（I 类或 III 类）失败，表现为反复出现症状 AF、AAD 无法耐受的副作用或 AAD 禁忌症
- 愿意并有能力提供同意
- 能够并愿意遵守所有预、后和后续测试和要求
排除标准：
- 继发于电解质不平衡、甲状腺疾病或可逆性或非心脏原因的房颤（例如，有记录的阻塞性睡眠呼吸暂停、急性酒精中毒等）
- 之前被诊断患有持续性 AF（持续时间超过 [>] 7 天）
- 既往接受过左心房 (LA) 消融或手术
- 已知需要在肺静脉 (PV) 区域外进行消融的参与者（例如，房室折返性心动过速、房室结折返性心动过速、室性心动过速和 Wolff-Parkinson-White），但用于消融典型右侧静脉三尖瓣峡部 (CTI) 线的参与者除外心房震颤
- 入组前 6 个月内影像学显示 LA 前后径严重扩张（左前降支 [LAD] >50mm）
- 手术后 48 小时内通过成像记录 LA 血栓
- 入组前 6 个月内通过影像学记录左心室射血分数严重受损（LVEF 低于 [<] 40% [%]）
- 不受控制的心力衰竭或纽约心脏协会 (NYHA) III 级或 IV 级
- 有凝血病史、出血异常或抗凝（肝素）禁忌症，既往接受过左心耳封堵术的受试者除外
- 过去 12 个月内记录的血栓栓塞事件（包括短暂性脑缺血发作 [TIA]）
- 2个月内患有不稳定型心绞痛、经皮冠状动脉介入治疗或急性心肌梗塞的参与者
- 过去 6 个月（180 天）内接受过冠状动脉旁路移植术 (CABG) 手术
- 心脏瓣膜手术/经皮手术（即心室切开术、心房切开术、瓣膜修复或置换以及人工瓣膜的存在）
- 6个月内不稳定型心绞痛
- 预计在未来 12 个月内进行心脏移植、心脏手术或其他重大手术
- 严重的肺部疾病（例如，限制性肺病、缩窄性或慢性阻塞性肺病）或任何其他导致严重慢性症状的肺部或呼吸系统疾病或功能障碍
- 显着的先天性异常（例如，房间隔缺损 [ASD]），包括研究者认为会排除参加本研究的修复缺陷或医疗问题
- 肺静脉狭窄的事先诊断
- 已有的半侧膈肌麻痹
- 急性疾病、活动性全身感染或败血症
- 存在心内血栓、粘液瘤、肿瘤、心房挡板或补片或其他妨碍导管引入或操作的异常
- 严重二尖瓣反流（反流体积大于或等于 [>=] 60 毫升 (mL)/次搏，反流分数 >= 50%，和/或有效反流口面积 >= 0.40 cm^2）
- 植入式起搏器、植入式心脏复律除颤器 (ICD)、最近植入（6 个月内）左心耳封堵 (LAAO) 装置或心腔内其他植入的金属心脏装置可能会干扰消融过程中产生的能量场
- 存在阻碍血管通路的疾病
- 目前正在参加一项评估其他设备或药物的研究
- 怀孕（如果是绝经前则通过妊娠测试证明）、哺乳期或育龄妇女并计划在临床研究过程中怀孕
- 预期寿命少于12个月
- 提出研究中使用的设备的禁忌症，如相应的使用说明 (IFU) 中所示
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：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：治疗组
患有药物难治性、症状性阵发性心房颤动的参与者将根据医院的标准方案（由研究者自行决定）使用 THERMOCOOL STSF 导管与 TRUPULSE 发生器结合接受 PFA/射频 (RF) 消融。
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THERMOCOOL STSF 将与 TRUPULSE 发生器结合使用，进行脉冲场 (PF) 消融或射频 (RF) 消融。
TRUPULSE 发生器将用于提供 PF/RF 消融。
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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 |
|---|---|---|
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发生主要不良事件 (PAE) 的参与者人数
大体时间：术后7天
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将报告使用 BWI 消融系统进行消融后 7 天内发生的 PAE（包括消融手术后 7 天以上发生的心房食管瘘和肺静脉狭窄）。
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术后7天
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没有记录在案的（有症状和无症状）心房颤动 (AF)、房性心动过速 (AT) 或心房扑动 (AFL) 发作和其他衰竭模式的参与者的百分比
大体时间：长达 274 天
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本研究的主要有效性终点是没有记录的无症状和有症状的 AF、AT 或 AFL 报告。
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长达 274 天
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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生活质量 (QOL) 改善与基线相比的变化
大体时间：从基线到消融手术后 12 个月
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生活质量将通过心房颤动对生活质量的影响 (AFEQT) 问卷总分进行评估。
分数范围从0到100，分数越高表明生活质量越好。
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从基线到消融手术后 12 个月
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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。
调查人员
- 研究主任：Biosense Webster Inc. Clinical Trial、Biosense Webster, Inc.
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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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 (实际的)
2023年12月7日
初级完成 (实际的)
2025年10月30日
研究完成 (实际的)
2025年10月30日
研究注册日期
首次提交
2023年11月17日
首先提交符合 QC 标准的
2023年11月17日
首次发布 (实际的)
2023年11月22日
研究记录更新
最后更新发布 (估计的)
2026年1月16日
上次提交的符合 QC 标准的更新
2026年1月15日
最后验证
2026年1月1日
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计划个人参与者数据 (IPD)
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IPD 计划说明
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访问研究数据的请求可以通过 YODA 项目网站提交：http://yoda.yale.edu
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不
研究美国 FDA 监管的设备产品
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