ACTRN12614000406606已完成未知
Steerable Sheath to access Pulmonary Veins in treatment of Paroxysmal Atrial Fibrillation (PAF) and Persistent Atrial Fibrillation at Christchurch Hospital
Kalila Medical0 个研究点目标入组 5 人开始时间: 2014年4月14日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •1.Suitable candidate for intra-cardiac mapping for
- •arrhythmias with documented PAF defined by HRS criteria.
- •2.Eighteen (18) to eighty (80) years of age
- •3.Signed Informed Consent
排除标准
- •1. Intracardiac thrombus, tumor or other abnormality that precludes
- •catheter introduction and placement
- •2. Severe cerebrovascular disease or history of cerebrovascular event
- •within one (1) month
- •3. Patients with severely impaired kidney function as measured by a
- •Cockcroft-Gault Glomerular Filtration Rate (GFR) 3 with a GFR < 29.
- •4. Active gastrointestinal bleeding, infection or fever (> 100.5/38C)
- •5. Severe co morbidity or Short life expectancy (<1 year) due to other illnesses such as cancer, pulmonary, hepatic or renal disease
- •6. Structural heart disease of clinical significance including
- •a. Symptoms of congestive heart failure including, but not limited to, NYHA Class III or IV CHF and/or documented ejection fraction < 40% measured by acceptable cardiac testing
- •b.Stable/unstable angina or ongoing myocardial ischemia
- •c.Myocardial infarction (MI) within three months of enrollment
- •d.Aortic or mitral valve disease > Grade II
- •e. Congenital heart disease (not including ASD or PFO without a right to left shunt) where the underlying abnormality increases the risk of an ablative procedure
- •7. Enrollment in any other ongoing arrhythmia study protocol
- •8. Any ventricular tachyarrhythmia currently being treated where the arrhythmia or the management may interfere with this study
- •9. Active infection or sepsis
- •10. Female patient is pregnant or lactating
- •11. Untreatable allergy to contrast media
- •12. Any diagnosis of atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiovascular causes
- •13. History of blood clotting (bleeding or thrombotic) abnormalities
- •14. Known sensitivities to heparin or warfarin
- •15. Severe COPD (identified by an FEV1 <1)
研究者
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