适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 7
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. Documented symptomatic PAF or PersAF. Documentation requirements are as
- •Paroxysmal:
- •Physician*s note indicating recurrent self-terminating AF AND
- •One electrocardiographically documented PAF episodes within 12 months.
- •Documented evidence of the PAF episode must either be continuous AF on a
- •12-lead ECG or include at least 30 seconds of AF from another ECG device.
- •Persistent: Continuous AF sustained beyond 7 days and less than 1 year that is
- •documented by
- •Physician's note, AND either
- •24-hour Holter within 180-days prior to the procedure, showing continuous AF,
- •Two electrocardiograms (from any form of rhythm monitoring) showing
- •continuous AF:
- •o that are taken at least 7 days apart but less than 12 months apart
- •o If electrograms are more than 12 months apart, there must be one or
- •more Sinus Rhythm
- •recordings in between or within 12 months prior to
- •consent/enrollment
- •with the most recent electrocardiogram within 180 days of enrollment.
- •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.
- •2. Plans to undergo a PVI catheter ablation procedure due to symptomatic PAF or
- •PersAF that is
- •refractory or intolerant to at least one Class I or III antiarrhythmic
- •3. At least 18 years of age
- •4. Able and willing to comply with all trial requirements including
- •pre-procedure, post- procedure,
- •and follow-up testing and requirements
- •5. 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
- •A patient will be excluded from enrollment in the clinical trial if he/she
- •meets any of the following criteria:
- •1. Previously diagnosed long-standing persistent atrial fibrillation (AF
- •greater than 1 year in
- •2. Arrhythmia due to reversible causes including thyroid disorders, acute
- •alcohol intoxication,
- •electrolyte imbalance, severe untreated sleep apnea, and other major
- •surgical procedures in
- •the preceding 90 days
- •3. Participant known to require ablation beyond PVI prior to initiating the
- •index procedure
- •4. Known presence of cardiac thrombus
- •5. Left atrial diameter >= 5.5 cm (anteroposterior diameter)
- •6. Left ventricular ejection fraction < 35% as assessed with echocardiography
- •within 180 days of
- •index procedure
- •7. New York Heart Association (NYHA) class III or IV heart failure
- •8. Body mass index > 40 kg/m2
- •9. Pregnant, nursing, or planning to become pregnant during the clinical
- •investigation follow-up
- •10. Patients who have had a ventriculotomy or atriotomy within the preceding 28
- •11. Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary
- •intervention (PCI),
- •or valve or coronary bypass grafting surgery within preceding 90 days
- •12. Unstable angina
- •13. Stroke or TIA (transient ischemic attack) within the last 90 days
- •14. Heart disease in which corrective surgery is anticipated within 180 days
- •after procedure
- •15. History of blood clotting or bleeding abnormalities including
- •thrombocytosis, thrombocytopenia,
- •bleeding diathesis, or suspected anti-coagulant sate
- •16. Contraindication to long term anti-thromboembolic therapy
- •17. Patient unable to receive heparin or an acceptable alternative to achieve
- •anticoagulation
- •18. Known sensitivity to contrast media (if needed during the procedure) that
- •cannot be controlled
- •with pre-medication
- •19. Previous left atrial surgical or catheter ablation procedure (including LAA
- •closure device)
- •20. Presence of any condition that precludes appropriate vascular access
- •21. Severe mitral regurgitation (regurgitant volume >= 60 mL/beat, regurgitant
- •fraction >= 50%, and/or
- •effective regurgitant orifice area >= 0.40cm2).
- •22. Previous tricuspid or mitral valve replacement or repair
- •23. Patients with prosthetic valves
- •24. Patients with a myxoma
- •25. Patients with an interatrial baffle or patch as the transseptal puncture
- •could persist and produce
- •an iatrogenic atrial shunt
- •26. Stent, constriction, or stenosis in a pulmonary vein
- 另有 15 项未显示
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