NL-OMON56476尚未招募不适用
Safety and Effectiveness Evaluation of the OMNYPULSE* Catheter with the TRUPULSE* generator for treatment of Paroxysmal Atrial Fibrillation (PAF) - Omny-IRE
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Diagnosed with Symptomatic Paroxysmal AF defined as 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
- •2. Selected for AF ablation procedure by pulmonary vein isolation (PVI).
- •3. Age 18-75 years.
- •4. Willing and capable of providing consent.
- •5. Able and willing to comply with all pre-, post- and follow-up testing and
- •requirements.
排除标准
- •1. Previously known AF secondary to electrolyte imbalance, thyroid disease, or
- •reversible or non-cardiac cause (e.g., documented obstructive sleep apnea,
- •acute alcohol toxicity, morbid obesity (Body Mass Index >40 kg/m²), renal
- •insufficiency (with an estimated creatinine clearance < 30 mL/min/1.73 m2) *.).
- •2. Previous LA ablation or surgery. 3. Patients known to require ablation
- •outside the PV region (e.g., atrioventricular reentrant tachycardia,
- •atrioventricular nodal re-entry tachycardia, atrial tachycardia, ventricular
- •tachycardia and Wolff-Parkinson-White). 4. Previously diagnosed with persistent
- •AF (> 7 days in duration). 5. Severe dilatation of the LA (LAD >50mm
- •antero-posterior diameter in case of Transthoracic Echocardiography (TTE)). 6.
- •Presence of LA thrombus. 7. Severely compromised Left Ventricular Ejection
- •Fraction (LVEF <40%). 8. Uncontrolled heart failure or New York Heart
- •Association (NYHA) Class III or IV. 9. History of blood clotting, bleeding
- •abnormalities or contraindication to anticoagulation (heparin, warfarin, or
- •dabigatran). 10. History of a documented thromboembolic event (including TIA)
- •within the past 6 months. 11. Previous Percutaneous Coronary Intervention (PCI)
- •/ Myocardial Infarction (MI) within the past 2 months. 12. Previous Coronary
- •Artery Bypass Grafting (CABG) in conjunction with valvular surgery, cardiac
- •surgery (e.g., ventriculotomy, atriotomy) or valvular cardiac (surgical or
- •percutaneous) procedure. 13. Unstable angina pectoris within the past 6 months.
- •14. Anticipated cardiac transplantation, cardiac surgery, or other major
- •surgery within the next 12 months. 15. Significant 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. 16. Known significant PV anomaly that in
- •the opinion of the investigator would preclude enrollment in this study. 17.
- •Prior diagnosis of pulmonary vein stenosis. 18. Pre-existing hemi diaphragmatic
- •paralysis. 19. Acute illness, active systemic infection, or sepsis. 20.
- •Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch
- •or other abnormality that precludes catheter introduction or manipulation. 21.
- •Severe mitral regurgitation. 22. Presence of implanted pacemaker or Implantable
- •Cardioverter-Defibrillator (ICD) or other implanted metal cardiac device that
- •may interfere with the pulsed electric field energy. 23. Presence of a
- •condition that precludes vascular access (such as Inferior Vena Cava (IVC)
- •filter) 24. Significant congenital anomaly or a medical problem that in the
- •opinion of the investigator would preclude enrollment in this study. 25.
- •Categorized as vulnerable population and requires special treatment with
- •respect to safeguards of well-being. 26. Current enrollment in an
- •investigational study evaluating another device or drug. 27. 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. 28. Life expectancy less than 12 months. 29. Presenting
- •contra-indications for the devices used in the study, as indicated in the
- •respective Instructions For Use (IFU). Additional exclu
研究者
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