ISRCTN93591221已完成未知
Prospective early feasibility study utilizing a novel mapping catheter for mapping in the atria and ventricles
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 30
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
- 性别
- All
入选标准
- •1. Diagnosed with and is a candidate for clinically-indicated catheter ablation procedure for the management of:
- •1.1. Ischemic ventricular tachycardia
- •1.2. Atrial tachycardia/atypical atrial flutter/paroxysmal atrial fibrillation following a pulmonary vein isolation ablation or mitral valve repair procedure
- •1.3. Persistent atrial fibrillation
- •2. Aged 18 years or older
- •3. Able to provide informed consent
- •4. Able and willing to comply with all pre-, post-, and follow-up testing and requirements
排除标准
- •1. History of continuous atrial fibrillation (AF) sustained longer than 12 months
- •2. History of AF <7 days and no previous AF ablation procedure
- •3. Previously diagnosed with long-standing persistent atrial fibrillation
- •4. Previously diagnosed with idiopathic PVC/VT
- •5. Study arrhythmia secondary to reversible cause
- •6. Atrial arrhythmias: patients with a left atrial size >55 mm
- •7. LVEF = 25% for VT patients
- •8. LVEF = 40% for AF patients
- •9. Documented thrombus in the chamber to be mapped by the study catheter on imaging
- •10. Contraindication to anticoagulation (i.e. heparin, warfarin, dabigatran)
- •11. History of blood clotting or bleeding abnormalities (e.g. hypercoagulable state)
- •12. Myocardial infarction within the past 2 months (60 days)
- •13. Documented thromboembolic event (including TIA) within the past 12 months (365 days)
- •14. Uncontrolled heart failure or NYHA function class III or IV
- •15. Implanted with a pacemaker or intracardiac cardiac defibrillator within the past 3 months (90 days)
- •16. Implanted with a prosthetic valve
- •17. Active systemic infection
- •18. Diagnosed atrial or ventricular myxoma
- •19. Implanted with an interatrial baffle or patch
- •20. Atrial septal closure within the past 6 weeks (42 days)
- •21. Presence of a condition that precludes vascular access
- •22. Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation
- •23. Women who are pregnant (as evidenced by pregnancy test if pre-menopausal)
- •24. Enrollment in an investigational study evaluating another device or drug
研究者
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