Cryoballoon pulmonary vein isolation vs. Cryoballoon pulmonary vein isolation with additional right atrial linear ablation for persistent atrial fibrillation: Prospective randomized trial (CRARAL 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: 2021年5月24日

适应症

试验速览

暂无简介。

•1. Patient with persistent atrial fibrillation (sustained beyond 7 days) who is scheduled for ablation procedure and =20 and =80 years of age
•2. Left atrium size < 45mm
•3. persistent 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 paroxysmal 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

发起方