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[未获得美国FDA批准或许可的器械试验] (CLEAR)

2026年7月10日 更新者：Abbott Medical Devices

[试验性设备，未经美国FDA批准或认证]

The objective of this clinical investigation is to evaluate the feasibility, safety, and effectiveness of a concomitant procedure involving the Volt PFA System and Amulet 2 device in patients indicated for both AF ablation and percutaneous LAAO.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

This clinical investigation is intended to evaluate the safety and feasibility of Abbott's Volt™ Pulsed Field Ablation (PFA) System (Volt PFA System) and Amulet™ 2 Left Atrial Appendage (LAA) occluder device (Amulet 2 device) in patients with non-valvular atrial fibrillation who are indicated for both atrial fibrillation (AF) ablation and LAA occlusion (LAAO)

研究类型

介入性

注册 (估计的)

240

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

  • 丹麦
    • Copenha
      • Copenhagen、Copenha、丹麦、2100
        • 招聘中
        • Rigshospitalet
  • 德国
    • Hesse
      • Frankfurt am Main、Hesse、德国、60389
        • 招聘中
        • Cardioangiologisches Centrum am Bethanien Krankenhaus
    • Schlesw
      • Lübeck、Schlesw、德国、23538
        • 招聘中
        • Universitätsklinikum Schleswig-Holstein - Campus Lübeck
    • State of Berlin
      • Berlin、State of Berlin、德国、13353
        • 招聘中
        • Deutsches Herzzentrum der Charité
  • 意大利
    • Italy
      • Milan、Italy、意大利、20138
        • 招聘中
        • Centro Cardiologico Monzino
    • Lombard
      • Milan、Lombard、意大利、20162
        • 招聘中
        • ASST Grande Ospedale Metropolitano
  • 捷克语
    • Czech Republic
      • Prague、Czech Republic、捷克语、1500
        • 招聘中
        • Motol and Homolka University Hospital
  • 比利时
    • B CAP R
      • Brussels、B CAP R、比利时、1090
        • 招聘中
        • UZ Brussel
  • 波兰
      • Lodz、波兰
        • 尚未招聘
        • Centralny Szpital Kliniczny Uniwersytetu
    • Silesian Voivodeship
      • Zabrze、Silesian Voivodeship、波兰、41-800
        • 尚未招聘
        • Slaskie Centrum Chorob Serca
  • 爱尔兰
    • Dublin
      • Dublin、Dublin、爱尔兰、Dublin 7
        • 招聘中
        • Mater Private Hospital
  • 立陶宛
    • Dzukija
      • Vilnius、Dzukija、立陶宛、08406
        • 招聘中
        • Vilnius University Hospital Santaros Klinikos
  • 英国
      • Brighton、英国
        • 尚未招聘
        • Royal Sussex County Hospital
      • Oxford、英国
        • 尚未招聘
        • John Radcliffe Hospital
  • 西班牙
    • Catalon
      • Barcelona、Catalon、西班牙、08025
        • 招聘中
        • Hospital de La Santa Creu i Sant Pau
    • Navarre
      • Pamplona、Navarre、西班牙、31008
        • 招聘中
        • Clinica Universidad de Navarra

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

Inclusion Criteria:

  • Subject must provide written informed consent prior to any clinical investigation-related procedure.
  • 18 years of age or older, or the age of legal consent
  • CHA2DS2-VASc score of ≥ 3 for women and ≥ 2 for men
  • Able to stop anticoagulation by 90 days post index procedure
  • Able to adhere to the protocol defined post-concomitant procedure pharmacologic regimen of OAC for at least 60 days followed by SAPT
  • Plans to undergo a catheter ablation procedure including PVI due to symptomatic, recurrent, drug-refractory PAF or PersAF
  • Documented symptomatic PAF or PersAF. Documentation requirements are as follows:

Paroxysmal:

  • Physician's note indicating recurrent self-terminating AF with ≥ 2 episodes of PAF within the 12 months prior to enrollment AND
  • One electrocardiographically documented PAF episode within 12 months prior to enrollment.

Persistent: Continuous AF sustained beyond 7 days and less than 1 year that is documented by

  • Physician's note, AND either
  • 24-hour Holter within 180 days prior to enrollment, showing continuous AF, OR

  • Two electrocardiograms (from any form of rhythm monitoring) showing continuous AF:

    • That are taken at least 7 days apart but less than 12 months apart
    • If electrograms are more than 12 months apart, there must be one or more Sinus Rhythm recordings in between or within 12 months prior to consent/enrollment
    • The most recent electrocardiogram must be within 180 days of enrollment.

NOTE: Documented evidence of the AF episode must either be continuous AF on a 12-lead ECG or include at least 30 seconds of continuous AF from another ECG device.

Exclusion Criteria:

  • Known contraindication or allergy to NOACs or aspirin, preventing use of the drugs post-procedure
  • Required to take P2Y12 platelet inhibitor after the study procedure (e.g., due to percutaneous coronary intervention)
  • Patients with heart prosthetic valves
  • Patient implanted with an inferior vena cava filter
  • Patients with left ventricular ejection fraction ≤30%
  • Patients with NYHA Class IV heart failure
  • Patients who have undergone any invasive intervention or surgery within 30 days prior to the index procedure (diagnostic catheterization is not within scope, however, percutaneous coronary intervention is within scope)
  • Patients who have experienced stroke or transient ischemic attack within 90 days prior to study procedure
  • Patients who have had previous attempt at LAA surgical or epicardial intervention (e.g., stapling, suturing, ligation, epicardial LAA management device)
  • Patients previously diagnosed long-standing persistent atrial fibrillation (Continuous AF greater than 1 year in duration)
  • Patients with arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, electrolyte imbalance, severe untreated sleep apnea, and other major surgical procedures within 90 days prior to the study procedure
  • Patients unable to receive heparin or an acceptable alternative to achieve adequate intra-procedural anticoagulation
  • Patients with a stent, constriction, or stenosis in a pulmonary vein
  • Patients with severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2)
  • Patients with severe renal failure (estimated glomerular filtration rate <30 ml/min/1.73m2) or on chronic dialysis
  • Patients with severe pulmonary disease (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms
  • Patients with hypertrophic cardiomyopathy (maximal LV wall thickness ≥ 15 mm in the absence of abnormal loading conditions such as hypertension or aortic stenosis)

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
实验性的：Treatment
Concomitant procedure utilizing the Volt PFA System and Amulet 2 device in patients indicated for both AF ablation and percutaneous LAAO implant.
程序：PVI Ablation
PVI Ablation with Pulsed Field Ablation
设备：Left Atrial Appendage Occluder Implant
Left atrial appendage occluder implant

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
LAA occlusion success determined by peri-device flow ≤5mm
大体时间：From treatment through 3-month follow-up vists
The primary effectiveness outcome is LAA occlusion defined as no peri-device flow or peri-device flow ≤5mm based on Doppler color flow TEE/TOE at the 3-month follow-up visit as assessed by an independent core laboratory
From treatment through 3-month follow-up vists
Occurrence of specific adverse events between time of implant and 7 days post-procedure or hospital discharge, whichever was later
大体时间：From implant of LAAO through ≤7 days post-procedure or hospital discharge, whichever is later

The primary safety outcome is defined as occurrence of one of the following between the time of implant and ≤7 days post-procedure or hospital discharge, whichever was later: death, ischemic stroke, systemic embolism, or device/procedure related complications requiring open cardiac surgery or major endovascular intervention

  • Includes pseudoaneurysm repair or AV fistula repair
  • Excludes percutaneous drainage of PE, snaring of embolized devices, thrombin injection or nonsurgical treatment of access site complications
From implant of LAAO through ≤7 days post-procedure or hospital discharge, whichever is later

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

Abbott Medical Devices

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)

2026年3月31日

初级完成 (估计的)

2027年5月31日

研究完成 (估计的)

2028年2月28日

研究注册日期

首次提交

2026年4月6日

首先提交符合 QC 标准的

2026年4月6日

首次发布 (实际的)

2026年4月13日

研究记录更新

最后更新发布 (实际的)

2026年7月13日

上次提交的符合 QC 标准的更新

2026年7月10日

最后验证

2026年7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

  • ABT-CIP-10617

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

是的

在美国制造并从美国出口的产品

是的

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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