Cryoballoon pulmonary vein isolation vs. Radiofrequency pulmonary vein isolation with additional right atrial linear ablation for paroxysmal atrial fibrillation: Prospective randomized trial (CRAPAF Trial)

Yonsei University Health System, Severance Hospital0 个研究点目标入组 330 人开始时间: 待定最近更新: 2019年10月7日

试验速览

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•1. Patient with paroxysmal atrial fibrillation (terminated within 7 days) who is scheduled for ablation procedure and =20 and =80 years of age
•2. Left atrium size < 45mm
•3. paroxysmal atrial fibrillation that is reccurrence during antiarrhythmic drug treatment or is not able to use an antiarrhythmic drug.
•4. Patient who is indicated for anticoagulation therapy (for prevention of cerebral infarction)

•1. Patients with persistent or permanent atrial fibrillation
•2. Atrial fibrillation associated with severe cardiac malformation or a structural heart disease that is hemodynamically affected
•3. Patients with severe renal impairment or CT imaging difficulty using contrast media
•4. Patients with a past history of radiofrequency ablation for atrial fibrillation or other cardiac surgery
•5. Patients with active internal bleeding
•6. Patients with contraindications for anticoagulation therapy(for prevention of cerebral infarction) and antiarrhythmic drugs
•7. Patients with valvular atrial fibrillation (mitral stenosis >grade 2, mechanical valve, mitral valvuloplasty)
•8. Patients with a severe comorbid disease
•9. Expected survival < 1 year
•10. Drug addicts or alcoholics
•11. Patients who cannot read the consent form (illiterates, foreigners, etc.)
•12. Other patients who are judged by the principal or sub-investigator to be ineligible for participation in this clinical study

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