适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Abbott
- 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
- 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 with >= 2 episodes
- •of PAF within the 6 months prior to enrollment AND
- •One electrocardiographically documented PAF episode within 12 months prior to
- •enrollment.
- •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 enrollment, showing continuous AF, OR
- •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
- •o The most recent electrocardiogram must be within 180 days of enrollment.
- •NOTE: 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 and is refractory, intolerant, or contraindicated to at least one Class
- •I-IV AAD medication
- •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
- •1. Previously diagnosed long-standing persistent atrial fibrillation
- •(Continuous AF greater than 1 year in duration)
- •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. Patient known to require ablation beyond PVI at the time of consent.
- •4. Known presence of cardiac thrombus
- •5. Left atrial diameter >= 5.5 cm (anteroposterior diameter) within 180 days of
- •index procedure.
- •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 period
- •10. Patients who have had a ventriculotomy or atriotomy within the preceding 30
- •days of procedure,
- •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 state
- •16. Contraindication to long term anti-thromboembolic therapy
- •17. Patient unable to receive heparin or an acceptable alternative to achieve
- •adequate 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 left atrial 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
- •27. Rheumatic heart disease
- •28. Hypertrophic cardiomyopathy
- •29. Diagnosed with amyloidosis or atrial amyloidosis
- •30. Active systemic infection
- •31. Renal failure requiring dialysis
- •32. Severe pulmonary disease (e.g., restrictive pulmonary disease, constrictive
- •or chronic obstructive pulmonary disease) or any other disease or malfunction
- 另有 8 项未显示
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