NL-OMON39542已完成不适用
Ablation as first line treatment of paroxysmal atrial fibrillation - AFLIT-PAF
Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 5 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
研究概览
简要总结
Trial ended prematurely
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Patients will be eligible for inclusion in the study if they meet all of the following inclusion criteria:
- •* Age between 18 and 65
- •* At least three episodes of paroxysmal atrial fibrillation documented on an electrocardiogram or event recording during the last three years
- •* Never taken antiarrhythmic drugs or at most a pill in the pocket approach
- •* Willingness, ability and commitment to participate in baseline and follow-up evaluations
排除标准
- •Subjects are excluded from the study if any of the following conditions are present (for all procedures):
- •* Paroxysmal AF for more than three years
- •* An episode of atrial fibrillation that lasted more than seven days within the past six months
- •* Persistent/permanent atrial fibrillation
- •* Atrial fibrillation from reversible cause (i.e. surgery, hyperthyroidism, pericarditis)
- •* Documented atrial flutter
- •* Structural heart disease of clinical significance including:
- •o Cardiac surgery within six months of screening
- •o Unstable symptoms of congestive heart failure (CHF) including NYHA Class III or IV CHF at screening and/or ejection fraction <30% as measured by echocardiography or catheterization
- •o Unstable angina
- •o Myocardial infarction within six months of screening
- •o Surgically corrected atrial septal defect with a patch or closure device
- •o LA size > 40mm
- •* Any prior ablation of the pulmonary veins
- •* Enrollment in any other ongoing protocol
- •* Untreatable allergy to contrast media
- •* Pregnancy
- •* Any contraindication to cardiac catheterization
- •* Prosthetic mitral heart valve
- •* Poor general health that, in the opinion of the Investigator, will not allow the patient to be a good study candidate (i.e. other disease processes, mental capacity, etc.)
- •* Contraindication to coumadin or heparin
- •* History of pulmonary embolus or stroke within one year of screening
- •* Acute pulmonary edema
- •* Atrial clot on TEE regardless of the patient*s anticoagulation medication status
研究者
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