OMNYPULSE カテーテルと TRUPULSE ジェネレーターを用いた発作性心房細動 (PAF) の治療に関する研究 (Omny-IRE)
発作性心房細動（PAF）治療用のTRUPULSEジェネレーターを備えたOMNYPULSEカテーテルの安全性と有効性の評価
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).
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Acquaviva delle Fonti、イタリア、70021
- Generale Regionale F. Miulli
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Maastricht、オランダ、6229 HX
- Maastricht UMC
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Quebec
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Montreal、Quebec、カナダ、H3G 1A4
- McGill University Health Centre
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Montreal、Quebec、カナダ、H1T 1C8
- Montreal Heart Institute
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Split、クロアチア、21000
- KBC Split
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Prague、チェコ、150 30 District 5
- Nemocnice na Homolce
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Prague、チェコ、140 21
- IKEM
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Frankfurt a.M.、ドイツ、60431
- MVZ CCB Frankfurt und Main Taunus GbR
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Aalst、ベルギー、9300
- AZORG campus Aalst Moorselbaan
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Bruges、ベルギー、8000
- AZ Sint-Jan
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Genk、ベルギー、3600
- Ziekenhuis Oost-Limburg
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Hasselt、ベルギー、3500
- Jessa Ziekenhuis - Campus Virga Jesse
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Vilnius、リトアニア、08661
- Vilnius University Hospital Santariskiu Klinikos
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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). |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Percentage of Participants With Primary Adverse Events (PAEs)
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Percentage of Participants With Freedom From Combined Documented (Symptomatic and Asymptomatic) Atrial Arrhythmia Episodes and Acute Procedural Failure
時間枠：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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協力者と研究者
スポンサー
捜査官
- スタディディレクター：Biosense Webster, Inc., a division of Johnson & Johnson Clinical Trial、Biosense Webster, Inc., a division of Johnson & Johnson
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- BWI202201
- BWI202201 (その他の識別子：Biosense Webster, Inc.)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。