NL-OMON49407撤回不适用
Safety and Effectiveness of TactiFlex* Ablation Catheter, Sensor Enabled* (TactiFlex SE) for the Treatment of Drug Refractory, Symptomatic, Paroxysmal Atrial Fibrillation (TactiFlex PAF IDE Trial) - TactiFlex PAF IDE Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 60
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. Plans to undergo a catheter ablation procedure due to symptomatic PAF that
- •is refractory or intolerant to at least one Class I or III antiarrhythmic drug.
- •2. Physician*s note indicating recurrent self-terminating AF
- •3. One electrocardiographically documented AF episode within 6-months prior to
- •the initial ablation procedure. Documented evidence of the AF episode must
- •either be continuous AF on a 12-lead ECG or include at least 30 seconds of AF
- •from another ECG device.
- •4. At least 18 years of age
- •5. Able and willing to comply with all trial requirements
- •6. Informed of the nature of the trial, agreed to its provisions and has
- •provided written informed consent as approved by the Institutional Review
- •Board/Ethics Committee (IRB/EC) of the respective clinical trial site.
排除标准
- •1. Persistent or long-standing persistent atrial fibrillation
- •2. Active systemic infection
- •3. Known presence of cardiac thrombus
- •4. Hypertrophic cardiomyopathy
- •5. Arrhythmia due to reversible causes including thyroid disorders, acute
- •alcohol intoxication, and other major surgical procedures in the 90-day period
- •preceding procedure
- •6. Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary
- •intervention (PCI), or valve or coronary bypass grafting surgery within 90 days
- •of procedure
- •7. Left atrial diameter > 5.0 cm measured within 180 days of procedure
- •(echocardiography or CT)
- •8. Left ventricular ejection fraction < 35% measured within 180 days of
- •procedure (echocardiography or CT)
- •9. New York Heart Association (NYHA) class III or IV
- •10. Previous left atrial surgical or catheter ablation procedure
- •11. Left atrial surgical procedure or incision with resulting scar (including
- •LAA closure device)
- •12. Previous tricuspid or mitral valve replacement or repair
- •13. Heart disease in which corrective surgery is anticipated within 180 days
- •after the procedure
- •14. Bleeding diathesis or suspected pro-coagulant state
- •15. Contraindication to long term anti-thromboembolic therapy
- •16. Presence of any condition that precludes appropriate vascular access
- •17. Renal failure requiring dialysis
- •18. Known sensitivity to contrast media (if needed during the procedure) that
- •cannot be controlled with pre-medication
- •19. Severe 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
- •20. Women who are pregnant or breastfeeding
- •21. Presence of other anatomic or comorbid condition that, in the
- •investigator*s opinion, could limit the patient*s ability to participate in the
- •clinical trial or to comply with follow up requirements, or impact the
- •scientific soundness of the clinical trial results
- •22. Patient is currently participating in another clinical trial or has
- •participated in a clinical trial within 30 days prior to screening that may
- •interfere with this clinical trial
- •23. Patient is unlikely to survive the protocol follow up period of 12-months
- •after the procedure
- •24. Body mass index > 40 kg/m2
- •25. Presence of other medical, social, or psychological conditions that, in the
- •investigator*s opinion, could limit the subject*s ability to participate in the
- •clinical investigation or to comply with follow-up requirements, or impact the
- •scientific soundness of the clinical investigation results.
- •26. Individuals without legal authority
- •27. Individuals unable to read or write
- •28. Patients who have had a ventriculotomy or atriotomy within the preceding 4
- •weeks of procedure,
- •29. Patients with prosthetic valves,
- 另有 5 项未显示
研究者
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