Safety and Effectiveness Evaluation of the OMNYPULSE Catheter With the TRUPULSE Generator for Treatment of Paroxysmal Atrial Fibrillation (PAF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 188
- 试验地点
- 25
- 主要终点
- Percentage of Participants With Primary Adverse Events (PAEs)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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).
干预措施: OMNYPULSE Bi-Directional Catheter with TRUPULSE Generator (Device)
结局指标
主要结局
Percentage of Participants With Primary Adverse Events (PAEs)
时间窗: 90 days post catheter insertion on Day 0
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.
Percentage of Participants With Acute Effectiveness Success
时间窗: Immediately post-procedure on Day 0 (post catheter insertion)
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.
次要结局
- Percentage of Participants With Freedom From Documented (Symptomatic and Asymptomatic) Atrial Arrhythmia Episodes and Acute Procedural Failure(From Day 91 to Day 365 post catheter insertion on Day 0)