HD Mapping Observational Study

St Jude Medical Abbott0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1.Subject must provide written informed consent for study participation and willing and able to comply with the protocol described evaluations and follow up schedule
•2.Subject must be over 18 years of age. (In Japan, the subject must be of 20 years of age or older)
•3.Subject is diagnosed with AF as defined by:
•3.1 Documented symptomatic paroxysmal AF defined as AF that terminates spontaneously or with intervention within 7 days of onset
•3.2 Documented symptomatic persistent AF defined as continuous atrial fibrillation that is sustained beyond 7 days but less than 12 months
•4.Subject is indicated for cardiac electroanatomical mapping and RF ablation procedure to treat AF
•5.Subject is planned to have electroanatomical mapping performed with the HD mapping catheters under investigation

•1.Previous ablation or surgery in the left atria
•2.Implanted left atrial appendage occluder
•3.Implanted mitral or tricuspid valve replacement
•4.Implanted cardiac defibrillator (ICD)
•5.Participation in another clinical investigation that may confound the results of this study
•6.Pregnant or nursing
•7.Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigatorâ??s opinion, could limit the subjectâ??s ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
•8.Life expectancy less than 12 months

发起方

St Jude Medical Abbott