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Evaluation of the FARAFLEX Mapping and Pulsed Field Ablation System in Subjects With Atrial Fibrillation (FARADIGM)

2026年10月21日 更新者：Boston Scientific Corporation

Evaluation of the FARAFLEX Mapping and Pulsed Field Ablation System in Subjects With Atrial Fibrillation - A Global Prospective Single Arm Study

The goal of this clinical trial is to learn if the FARAFLEX™ Mapping and pulsed field ablation (PFA) System can safely and effectively treat symptomatic, drug-refractory Paroxysmal atrial fibrillation (PAF) and Persistent atrial fibrillation (PersAF). The main question it aims to answer is:

Is the FARAFLEX Mapping and PFA System a safe and effective treatment for patients?

Participants will undergo an ablation procedure using the FARAFLEX Mapping and PFA System.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

571

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

研究联系人备份

学习地点

  • 比利时
      • Bruges、比利时、B-8000
  • 爱尔兰
    • Dublin
      • Dublin、Dublin、爱尔兰、D07 RD8P
  • 美国
    • Arkansas
      • Jonesboro、Arkansas、美国、72401
    • Georgia
      • Atlanta、Georgia、美国、30342
        • 招聘中
        • Emory Saint Joseph's Hospital
        • 首席研究员：
          • David DeLurgio
        • 接触：
    • Iowa
      • West Des Moines、Iowa、美国、50266
        • 招聘中
        • Mercy Hospital Medical Center
        • 首席研究员：
          • Troy Hounshell
        • 接触：
    • Massachusetts
      • Boston、Massachusetts、美国、02114
        • 招聘中
        • Massachusetts General Hospital-Hospital
        • 首席研究员：
          • Moussa Mansour
        • 接触：
    • New York
      • New York、New York、美国、10029
        • 招聘中
        • Mount Sinai Medical Center-Hospital
        • 首席研究员：
          • Mohit Turagam
        • 接触：
    • Ohio
      • Columbus、Ohio、美国、43214
        • 招聘中
        • OhioHealth Research and Innovation Institute - Riverside Methodist Hospital
        • 首席研究员：
          • Auroa Badin
        • 接触：
    • Pennsylvania
      • Mechanicsburg、Pennsylvania、美国、17050
        • 招聘中
        • Pinnacle Health at Harrisburg Hospital - UPMC Pinnacle
        • 接触：
        • 首席研究员：
          • Patel Chinmay
    • South Carolina
      • Charleston、South Carolina、美国、29406
    • Texas
      • Austin、Texas、美国、78705
      • Tyler、Texas、美国、75701
        • 招聘中
        • Christus Trinity Mother Frances Health System-Hospital
        • 首席研究员：
          • Stanislav Weiner
        • 接触：
  • 西班牙
      • Pamplona、西班牙、31008
        • 招聘中
        • Clínica Universidad de Navarra
        • 接触：
        • 首席研究员：
          • Jose Ignacio Garcia Bolao

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:

  1. At least 18 years old (or older if required by local law)
  2. Symptomatic, documented, drug-refractory paroxysmal or persistent atrial fibrillation (AF).
  3. Willing and capable of providing written informed consent
  4. Willing and able to comply with all follow-up assessments and study procedures at an approved investigational site

Exclusion Criteria:

  1. Any of the following atrial conditions:

    1. Left atrial anteroposterior diameter of at least 5.5 cm, or if not available, non-indexed volume greater than 100 mL
    2. Any prior atrial endocardial, epicardial, or surgical ablation for atrial arrhythmia (excluding right-sided Supraventricular Tachycardia (SVT) or Cavo-Tricuspid Isthmus (CTI)-dependent flutter)
    3. Any prior atrial surgery
    4. Current atrial myxoma
    5. Pulmonary vein abnormality, stenosis, or prior stenting (common and middle pulmonary veins allowed)
    6. Current left atrial thrombus

  2. Any of the following cardiovascular conditions:

    1. History of sustained ventricular tachycardia or ventricular fibrillation

    2. Atrial fibrillation secondary to reversible or non-cardiac causes (e.g., electrolyte imbalance, thyroid disease, alcohol)

    3. Presence of any of the following cardiac devices or implants:

      • Current or anticipated pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy device
      • Current implantable loop recorder other than LUX-Dx
      • Prior interatrial baffle or septal closure device/patch (Patent Foramen Ovale (PFO)or Atrial Septal Defect (ASD))
      • Left atrial appendage closure or occlusion device

    4. Clinically significant valvular disease, including:

      • Any cardiac valve prosthesis, ring, repair, or clip
      • Moderate to severe mitral stenosis
      • Moderate to severe aortic stenosis
      • Severe mitral regurgitation
      • Severe tricuspid regurgitation

    5. Hypertrophic or amyloid cardiomyopathy

    6. Presence of Inferior Vena Cava (IVC) filter, inability to obtain vascular access, or contraindication to femoral access

    7. Awaiting cardiac transplantation or other cardiac surgery within 12 months (left atrial appendage closure/occlusion procedures allowed no less than (≥) 60 days after index procedure)

    8. Severe right ventricular dysfunction per investigator assessment

  3. Any of the following congenital conditions:

    1. Congenital heart disease with clinically significant residual anatomic or conduction abnormalities, or channelopathies
    2. Known congenital methemoglobinemia
    3. Known G6PD deficiency

  4. Any of the following medical history conditions:

    1. Solid organ or hematologic transplant, or under evaluation for transplant
    2. History or current evidence of hemi-diaphragmatic paralysis or paresis
    3. Prinzmetal angina or severe non-revascularizable coronary disease
    4. Known coagulopathy or bleeding disorder
    5. Renal insufficiency, history of dialysis, or renal transplant
    6. Known allergic reaction to nitroglycerin (excluding hypotension)
    7. Required use of phosphodiesterase inhibitors within 24 hours of the ablation procedure
    8. Active spinal cord stimulator

  5. Any of the following baseline conditions:

    1. NYHA Class III or IV heart failure
    2. Left ventricular ejection fraction (LVEF) less than 40% within 12 months
    3. CHA2DS2-VASc score greater than or equal to 5
    4. Body mass index (BMI) greater than 45.0
    5. Contraindication to or unwillingness to use systemic anticoagulation peri-procedurally
    6. Pregnant or lactating at time of procedure
    7. Severe lung disease, pulmonary hypertension, or oxygen-dependent lung disease
    8. Active malignancy (excluding squamous cell carcinoma)
    9. Clinically significant gastrointestinal disease (e.g., severe or erosive esophagitis, uncontrolled reflux, gastroparesis, esophageal candidiasis, active gastroduodenal ulceration)
    10. Known Active systemic infection
    11. Life expectancy of less than 1 year
    12. Concurrent enrollment in another investigational study or registry that may interfere with this study (exceptions include mandatory governmental registries or purely observational registries with sponsor approval)

  6. Any of the following events within 90 days prior to consent:

    1. Myocardial infarction, unstable angina, or coronary intervention
    2. Pericarditis or symptomatic pericardial effusion
    3. Gastrointestinal bleeding
    4. Cardiac surgery
    5. Stroke, Transient Ischemic Attack (TIA), or intracranial bleeding
    6. Any active non-neurologic thrombus and/or thromboembolic event
    7. Carotid stenting or endarterectomy
    8. Heart failure hospitalization
    9. Uncontrolled diabetes mellitus or HbA1c greater than 8.0%

  7. Other conditions:

    1. Unwillingness to receive, or unable to tolerate, a subcutaneous, chronically inserted ICM from the LUX-Dx family of devices
    2. Any medical condition that, in the investigator's opinion, would interfere with study participation, increase risk, or affect data interpretation

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：FARAFLEX Mapping and Pulsed Field Ablation (PFA) System

Participants undergo a catheter procedure using the FARAFLEX Mapping and Pulsed Field Ablation (PFA) System to treat atrial fibrillation. The catheter is used to map the heart's electrical signals and deliver pulsed field ablation therapy.
设备：FARAFLEX Mapping and Pulsed Field Ablation (PFA) System

Catheter used to perform cardiac electrophysiological mapping and deliver cardiac tissue ablation therapy for the treatment of Atrial Fibrillation.

其他名称：
  • FARAFLEX Mapping and Pulsed Field Ablation (PFA) Catheter
  • FARAFLEX Catheter

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
Proportion of Treatment Subjects and Attempt Subjects with device- or procedure-related defined Composite Serious Adverse Events, assessed through Day 60 following the index procedure.
大体时间：After the index procedure, rescheduled index procedure, or first re-ablation performed with the FARAFLEX (Day 0) through Day 60

Occurrence of defined Composite Serious Adverse Events after the procedure through Day 60.
After the index procedure, rescheduled index procedure, or first re-ablation performed with the FARAFLEX (Day 0) through Day 60
The primary effectiveness endpoint (PEE) is the proportion of Treatment Subjects with Treatment Success through the Day 365 Assessment.
大体时间：Day 0 through the Day 365 Assessment

Acute Procedural Success defined as Pulmonary Vein (PV) Isolation and Chronic Success. Chronic Success is defined as freedom from the following after the Blanking Period (60 days):

  • Arrhythmia: Occurrence of any Detectable Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachycardia (AT)
  • Re-ablation: Any re-ablation for Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachycardia (AT)
  • Cardioversion: Any electrical cardioversion for Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachycardia (AT)
  • Antiarrhythmic Drug (AAD) Use: dose increase from the historic maximum ineffective dose (prior to the ablation procedure) or initiation of a new AAD.
Day 0 through the Day 365 Assessment

次要结果测量

结果测量
措施说明
大体时间
Atrial Arrhythmia Burden Success Endpoint
大体时间：Post-blanking period (Day 60) through 6 months (Day 180)

Atrial Arrhythmia Burden Success is defined as the proportion of Treatment subjects with atrial arrhythmia burden less than or equal to 0.1% in the time period post-blanking period through 6 months, as measured by LUX-Dx.
Post-blanking period (Day 60) through 6 months (Day 180)
Cavo-Tricuspid Isthmus (CTI) Ablation - Acute Procedural Endpoint
大体时间：Index Ablation Procedure

Defined as the proportion of Treatment Subjects who underwent a Cavo-Tricuspid Isthmus (CTI) ablation during the Index Procedure, regardless of the atrial fibrillation cohort, with absence of conduction through the cavo-tricuspid isthmus in both directions (bidirectional block), achieved with the FARAFLEX™ Mapping and PFA Catheter only, and confirmed prior to the end of the Index Ablation Procedure.
Index Ablation Procedure

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

Boston Scientific Corporation

调查人员

  • 首席研究员：Andrea Natale, MD、Texas Cardiac Arrhythmia Research Foundation

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7月7日

初级完成 (估计的)

2028年7月20日

研究完成 (估计的)

2030年1月1日

研究注册日期

首次提交

2026年5月4日

首先提交符合 QC 标准的

2026年5月4日

首次发布 (实际的)

2026年5月8日

研究记录更新

最后更新发布 (实际的)

2026年10月23日

上次提交的符合 QC 标准的更新

2026年10月21日

最后验证

2026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

  • PF314

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

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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