使用 OMNYPULSE 导管和 TRUPULSE 发生器治疗阵发性心房颤动 (PAF) 的研究 (Omny-IRE)
带有 TRUPULSE 发生器的 OMNYPULSE 导管治疗阵发性心房颤动 (PAF) 的安全性和有效性评估
The purpose of this study is to demonstrate safety and effectiveness of the ablation system (OMNYPULSE Bi-directional catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF).
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Split、克罗地亚、21000
- KBC Split
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Quebec
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Montreal、Quebec、加拿大、H3G 1A4
- McGill University Health Centre
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Montreal、Quebec、加拿大、H1T 1C8
- Montreal Heart Institute
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Frankfurt a.M.、德国、60431
- MVZ CCB Frankfurt und Main Taunus GbR
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Acquaviva delle Fonti、意大利、70021
- Generale Regionale F. Miulli
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Prague、捷克语、150 30 District 5
- Nemocnice na Homolce
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Prague、捷克语、140 21
- IKEM
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Aalst、比利时、9300
- AZORG campus Aalst Moorselbaan
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Bruges、比利时、8000
- AZ Sint-Jan
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Genk、比利时、3600
- Ziekenhuis Oost-Limburg
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Hasselt、比利时、3500
- Jessa Ziekenhuis - Campus Virga Jesse
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Vilnius、立陶宛、08661
- Vilnius University Hospital Santariskiu Klinikos
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Maastricht、荷兰、6229 HX
- Maastricht UMC
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Diagnosed with Symptomatic paroxysmal atrial fibrillation (PAF) defined as as atrial fibrillation (AF) that terminates spontaneously or with intervention within 7 days of onset. This PAF is considered to be symptomatic if symptoms related to AF are experienced by the participant
- Selected for AF ablation procedure by pulmonary vein isolation (PVI)
- Willing and capable of providing consent
- Able and willing to comply with all pre-, post- and follow-up testing and requirements
Exclusion Criteria:
- Previously known AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (example, documented obstructive sleep apnea, acute alcohol toxicity, morbid obesity [body mass index greater than {>} 40 kilograms per meter square {kg/m^2}]), renal insufficiency (with an estimated creatinine clearance less than (<) 30 milliliters per minute per 1.73 meter square [mL/min/1.73 m^2])
- Previous left atrium (LA) ablation or surgery
- Participants known to require ablation outside the PV region (example, atrioventricular reentrant tachycardia, atrioventricular nodal re-entry tachycardia, atrial tachycardia, ventricular tachycardia and Wolff-Parkinson-White)
- Previously diagnosed with persistent AF (> 7 days in duration)
- Severe dilatation of the left atrium (LA) (left anterior descending artery [LAD] >50 millimeter [mm] antero-posterior diameter in case of transthoracic echocardiography [TTE])
- Presence of LA thrombus
- Severely compromised left ventricular ejection fraction (left ventricular ejection fraction [LVEF] <40 percentage [%])
- Uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV
- History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran)
- History of a documented thromboembolic event (including transient ischemic attack [TIA]) within the past 6 months
- Previous percutaneous coronary intervention (PCI) / myocardial infarction (MI) within the past 2 months
- Previous coronary artery bypass grafting (CABG) in conjunction with valvular surgery, cardiac surgery (example, ventriculotomy, atriotomy) or valvular cardiac (surgical or percutaneous) procedure
- Unstable angina pectoris within the past 6 months
- Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months
- Significant pulmonary disease (example, 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
- Known significant pulmonary vein (PV) anomaly that in the opinion of the investigator would preclude enrollment in this study
- Prior diagnosis of pulmonary vein stenosis
- Pre-existing hemi diaphragmatic paralysis
- Acute illness, active systemic infection, or sepsis
- Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation
- Severe mitral regurgitation
- Presence of implanted pacemaker or implantable cardioverter-defibrillator (ICD) or other implanted metal cardiac device that may interfere with the pulsed electric field energy
- Presence of a condition that precludes vascular access (such as Inferior Vena Cava [IVC] filter)
- Significant congenital anomaly or a medical problem that in the opinion of the investigator would preclude enrollment in this study
- Categorized as vulnerable population and requires special treatment with respect to safeguards of well-being
- Current enrollment in an investigational study evaluating another device or drug
- Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of child-bearing age and plan on becoming pregnant during the course of the clinical investigation
- Life expectancy less than 12 months
- Presenting contra-indications for the devices used in the study, as indicated in the respective Instructions For Use (IFU)
- Known contraindication for magnetic resonance imaging (MRI) such as use of contrast agents due to advanced renal disease, claustrophobia etcetra. (at principle investigator [PI] discretion)
- Presence of iron-containing metal fragments in the body
- Known unresolved pre-existing neurological deficit
- Known uncontrolled significant gastroesophageal reflux disease (GERD)
学习计划
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：OMNYPULSE Bi-Directional Catheter with TRUPULSE Generator
Participants with symptomatic paroxysmal atrial fibrillation (PAF) will undergo the ablation procedure with OMNYPULSE bi-directional catheter used in combination with the TRUPULSE generator for pulmonary vein isolation (PVI). |
Participants will undergo catheter ablation with the PF ablation system consisting of the TRUPULSE generator (delivers PF energy through the study catheter) and the OMNYPULSE bi-directional catheter (indicated for use in catheter-based cardiac electrophysiological mapping [stimulating and recording] and, when used with a Generator, for cardiac ablation). |
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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Percentage of Participants With Primary Adverse Events (PAEs)
大体时间：90 days post catheter insertion on Day 0
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Percentage of participants with PAEs was reported. PAEs (within seven [7] days of the index ablation procedure) included the following adverse events atrio-esophageal fistula, pulmonary vein stenosis, device or procedure related death, (up to 90 days post-procedure), phrenic nerve paralysis (permanent), cardiac tamponade/perforation (up to 30 days post-procedure), stroke/cerebrovascular accident (CVA), major vascular access complication, major bleeding, thromboembolism, myocardial infarction, transient ischemic attack (TIA), pericarditis, heart block, pulmonary edema (respiratory insufficiency), and vagal nerve injury/gastroparesis. |
90 days post catheter insertion on Day 0
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Percentage of Participants With Acute Effectiveness Success
大体时间：Immediately post-procedure on Day 0 (post catheter insertion)
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Percentage of participants with acute effectiveness success were reported. Procedural success was defined as electrical isolation of clinically relevant targeted pulmonary veins (PV; confirmed by entrance block) after adenosine/isoproterenol challenge at the end of the index ablation procedure. |
Immediately post-procedure on Day 0 (post catheter insertion)
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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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Percentage of Participants With Freedom From Combined Documented (Symptomatic and Asymptomatic) Atrial Arrhythmia Episodes and Acute Procedural Failure
大体时间：From Day 0 to Day 365 post catheter insertion on Day 0
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Percentage of participants with freedom from combined documented (symptomatic and asymptomatic) atrial arrhythmia episodes and acute procedural failure were reported. Effectiveness success was defined as freedom from documented (symptomatic and asymptomatic) atrial arrhythmia (atrial fibrillation, atrial tachycardia or atrial flutter [AFL] of unknown origin [all AFL except those Cavotricuspid Isthmus (CTI) dependent AFL as confirmed by 12-lead electrocardiogram or entrainment maneuvers in an EP study]) episodes based on electrocardiographic data (greater than or equal to [>=] 30 seconds on arrhythmia monitoring device) during the effectiveness evaluation period (Day 91 to Day 365) on or off antiarrhythmic therapy. Acute procedural failure: failure to achieve entrance block with the study device in any of the clinically relevant targeted pulmonary veins (PVs). Kaplan-Meier (KM) estimate was used. |
From Day 0 to Day 365 post catheter insertion on Day 0
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合作者和调查者
调查人员
- 研究主任：Biosense Webster, Inc., a division of Johnson & Johnson Clinical Trial、Biosense Webster, Inc., a division of Johnson & Johnson
出版物和有用的链接
一般刊物
- Duytschaever M, Grimaldi M, De Potter T, Verma A, Macle L, Kautzner J, Linz D, Anic A, Van Herendael H, Rackauskas G, Neuzil P, Chun J, Schmidt B, Knecht S, Almorad A, Berte B, Reddy VY, Vijgen J. PVI With CF-Sensing Large-Tip Focal PFA Catheter With 3D Mapping for Paroxysmal AF: Omny-IRE 3-Month Results. JACC Clin Electrophysiol. 2025 Aug;11(8):1769-1782. doi: 10.1016/j.jacep.2025.04.008. Epub 2025 Apr 25.
- Duytschaever M, Vijgen J, Neuzil P, Grimaldi M, Verma A, De Potter T, Macle L, Kautzner J, Linz D, Anic A, Chun J, Van Herendael H, Almorad A, Berte B, Bhardwaj R, Reichlin T, Mansour M, Schmidt B, Knecht S, Reddy VY, Rackauskas G. Pulmonary vein isolation with a contact force-sensing, large-tip focal pulsed field ablation catheter with 3D mapping for paroxysmal atrial fibrillation: Omny-IRE 12-month results. Heart Rhythm. 2026 Oct 22:S1547-5271(26)02869-9. doi: 10.1016/j.hrthm.2026.10.008. Online ahead of print.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- BWI202201
- BWI202201 (其他标识符：Biosense Webster, Inc.)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) project site at yoda.yale.edu
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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