ISRCTN11764506已完成未知
Prospective, multi-center, single-arm, early feasibility utilizing a novel radiofrequency ablation catheter
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 39
研究概览
简要总结
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31826648 (added 13/12/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Symptomatic paroxysmal atrial fibrillation with at least one documented atrial fibrillation episode within one year prior to enrollment
- •2. Failed at least one antiarrhythmic drug (class I or III)
- •3. Pre-procedural anticoagulation on warfarin, rivaroxaban or apixaban. If receiving warfarin therapy, patients must agree to take warfarin for at least 4 weeks prior to the scheduled ablation procedure.
- •4. Age 18 years or older
- •5. Able and willing to comply with all pre-, post- and follow-up testing and requirements (e.g. Patient not confined by a court ruling)
- •6. Signed Patient Informed Consent Form
排除标准
- •1. Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
- •2. Previous surgical or catheter ablation for atrial fibrillation
- •3. Previously diagnosed with persistent or longstanding atrial fibrillation
- •4. Any percutaneous coronary intervention (PCI), cardiac surgery, or valvular cardiac surgical or percutaneous procedure (e.g. ventriculotomy, atriotomy) within the past 2 months
- •5. Valve repair or replacement and presence of a prosthetic valve
- •6. Any carotid stenting or endarterectomy
- •7. Coronary artery bypass grafting surgery within the past 6 months
- •8. Documented left atrium thrombus on baseline/pre-procedure imaging
- •9. LA size > 55 mm
- •10. Left Ventricular Ejection Fraction (LVEF) < 40%
- •11. Contraindication to anticoagulation (heparin or warfarin)
- •12. Contraindication to use of contrast agents for MRI such as advanced renal disease, etc.
- •13. History of blood clotting or bleeding abnormalities
- •14. Myocardial infarction within the past 2 months
- •15. Documented thromboembolic event (including transient ischemic attack [TIA]) within the past 12 months
- •16. Rheumatic Heart Disease
- •17. Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV
- •18. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months
- •19. Unstable angina
- •20. Acute illness or active systemic infection or sepsis
- •21. Diagnosed atrial myxoma
- •22. Presence of implanted pacemaker, implantable cardioverter defibrillator (ICD), or tissue-embedded, iron-containing metal fragments
- •23. 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 chronic symptoms
- •24. Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in this study
- •25. Unresolved pre-existing neurological deficit
- •26. 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
- •27. Enrollment in an investigational study evaluating another device, biologic, or drug
- •28. Has known pulmonary vein stenosis
- •29. Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter
- •30. Presence of a condition that precludes vascular access
- •31. Life expectancy or other disease processes likely to limit survival to less than 12 months
- •32. Presenting contra-indication for the devices (e.g. esophageal endoscope, CT, etc.) used in the study, as indicated in the respective instructions for use
- •33. Categorized as a vulnerable population and require special treatment with respect to safeguards of well-being (e.g. cognitively impaired, veteran, prisoner, etc.)
研究者
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