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临床试验/DRKS00010429
DRKS00010429招募中未知

Pulmonary Vein Isolation (PVI) versus PVI plus Selective Ablation of Low VoltagE Areas for Persistent Atrial Fibrillation (SOLVE-AF) – A Randomized Multi-Center Trial - SOLVE-AF

niversitäts-Herzzentrum Freiburg-Bad Krozingen0 个研究点目标入组 450 人开始时间: 2017年8月10日最近更新:
适应症

试验速览

阶段
未知
状态
招募中
发起方
入组人数
450

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
Randomized controlled study
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. Age =18 years and <80 years
  • 2. Eligibility for first ablation procedure for symptomatic persistent AF (>7days and <12 months longest AF duration)
  • 3. Written informed consent obtained according to international guidelines and local laws
  • 4. Ability to understand the nature of the trial and the trial related procedures and to comply with them

排除标准

  • 1. Previous ablation for AF
  • 2. Contra-indications for AF catheter ablation therapy (thrombus in left atrium (LA), at TEE high risk for bleeding under anticoagulant therapy, short life expectancy)
  • 3. Patients with paroxysmal AF (<7 days persisting)
  • 4. Patients with long standing AF (>12 months)
  • 5. LA diameter >55 mm
  • 6. Hyperthyroidism
  • 7. Heart failure, NYHA 3 and 4
  • 8. Valvular AF (Mitral or aortic valvulopathy >Grade 2/3)
  • 9. Other major disabling disease
  • 10. Current pregnancy

研究者

发起方
niversitäts-Herzzentrum Freiburg-Bad Krozingen

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