跳至主要内容
临床试验/NCT06669637
NCT06669637尚未招募不适用

Amplify EP Registry

Heart Rhythm Clinical and Research Solutions, LLC0 个研究点目标入组 1,100 人开始时间: 2024年11月22日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,100
主要终点
Long term effectiveness

研究概览

简要总结

An observational, prospective, multi-center, non-randomized registry designed to obtain real world clinical experience with the TactiFlex Catheter Ablation system in the treatment of Atrial Fibrillation. Patient assessments will occur at pre procedure and procedure, and 1 year post ablation

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients who, in the opinion of the investigator, are candidates for ablation to treat atrial fibrillation.
  • Plans to undergo an ablation procedure using the TactiFlex Ablation Catheter™, Sensor Enabled™ (TactiFlex SE) manufactured by Abbott.
  • De Novo or redo AF catheter ablation procedures.
  • Able and willing to participate in baseline and all follow up evaluations.
  • 18 years of age or older.

排除标准

  • Enrolled in any other cardiac device clinical trial, investigational drug trial, or any other trial that may confound the results of the ablation procedure.
  • In the opinion of the investigator, any known contraindication to an ablation procedure or to any device or drug required for use during an ablation procedure as assessed by the investigator.

结局指标

主要结局

Long term effectiveness

时间窗: 12-month

defined as freedom from recurrence of AF/AT/AFL \>30 sec at 12-month follow-up

次要结局

  • Acute success(at time of procedure)
  • Acute safety(30 days)
  • Long term safety(12 months)

研究者

申办方类型
Other
责任方
Sponsor

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