NL-OMON46588已完成不适用
Clinical Investigation of the VytronUS Ablation System for Treatment <br>of Symptomatic Drug-refractory Paroxysmal Atrial Fibrillation - VITA
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
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 64（—）
入选标准
- •1. Age between 18 and 75 years
- •2. History of symptomatic recurrent paroxysmal atrial fibrillation (PAF) in the prior year, defined by:
- •a. Two or more symptomatic AF episodes lasting greater than 30 seconds duration that self-terminate and lasting no more than 7 continuous days. An episode of AF * 48 hours duration terminated with electrical or pharmacologic cardioversion counts as a paroxysmal atrial fibrillation episode.
- •b. At least one episode of paroxysmal atrial fibrillation (PAF) documented on 12-lead ECG, event monitor, or telemetry monitor in the prior year
- •3. Paroxysmal atrial fibrillation refractory to at least one Beta Blocker, Calcium Channel Blocker, or Class I or Class III anti-arrhythmic drug (AAD).
- •4. Subject is indicated for a pulmonary vein ablation according to society guidelines or investigational site practice.
- •5. Subject is able and willing to give informed consent.
- •6. Willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full duration of the study
排除标准
- •1. Prior LA ablation or surgery
- •2. Persistent, longstanding persistent, or permanent AF
- •3. AF secondary to electrolyte imbalance, thyroid disease or reversible or non-cardiac cause
- •4. NYHA Class III or IV congestive heart failure
- •5. Rheumatic heart disease
- •6. Atrial myxoma
- •7. LVEF <40% measured by acceptable cardiac testing (e.g. TTE, TEE)
- •8. Anteroposterior LA diameter >5.5cm or <3.5cm by TTE, CT or MRI
- •9. Presence of intracardiac thrombus (including a known history of thrombus) within 30 days prior to the index ablation procedure
- •10. Presence of pulmonary vein stent(s)
- •11. Presence of pre-existing pulmonary narrowing or pulmonary vein stenosis greater than 70%
- •12. Presence of pre-existing pericardial effusion
- •13. Previous mitral valve repair or prosthesis
- •14. Bleeding diathesis or contraindication to anticoagulation therapy
- •15. Known blood clotting abnormalities (e.g., genetic)
- •16. MI, PCI, or cardiac surgery within 90 days prior to the index ablation procedure
- •17. Previous CVA, TIA, or PE within 3 months prior to the index procedure
- •18. Structural heart defect that, in the investigator*s opinion, prevents catheter access or increases risk of ablation procedure
- •19. Pacemaker, ICD, or CRT with pacing leads implanted within 3 months prior to the index ablation procedure
- •20. Subjects in whom PVI is contraindicated based on an intra-procedural finding such as AVRT/AVNRT will be excluded from the primary endpoint analyses and followed for safety only
- •21. Active systemic infection
- •22. Subject contraindicated for both contrast MRI and CT
- •23. Life expectancy less than 360 days in physician*s opinion
- •24. Participation in a drug or device study that could conflict with this study
- •25. Women known to be pregnant or breastfeeding or of childbearing potential unless on satisfactory contraceptive routine
- •26. Exclusion as per local laws
研究者
相似试验
已完成
不适用
Clinical Investigation of the VytronUS Ablation System for Treatment of Paroxysmal Atrial FibrillationParoxysmal Atrial FibrillationNCT03639597VytronUS, Inc.53
Unknown
不适用
Clinical Investigation of the VytronUS Ablation System for Treatment of Symptomatic Drug-refractory Paroxysmal Atrial FibrillationParoxysmal Atrial FibrillationNCT03513029VytronUS, Inc.100
已完成
不适用
ExAblate UF V2 System for the Treatment of Symptomatic Uterine FibroidsUterine FibroidsNCT01285960InSightec108
撤回
不适用
Clinical evaluation of the Gen2 irrigated ablation catheter for the treatment of cardiac arrhythmias10007521Atrial fibrillationNL-OMON31563St. Jude Medical103
尚未招募
不适用
Vision-MR Ablation Catheter 2.0 for Treatment of Ventricular Tachycardia10007521Ventricular TachycardiaCardiac arrhythmiaNL-OMON53247Imricor Medical Systems, Inc45