Real-world Assessment of QDOT MICRO Catheter-based Pulmonary Vein Isolation with Therapeutic Strategy for Persistent Atrial Fibrillation

Goya Masahiko0 个研究点目标入组 1,000 人开始时间: 2023年7月1日最近更新: 2023年10月17日

试验速览

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•Subject must meet ALL of the following inclusion criteria to be eligible for enrollment into the study:
•1.Signed and dated the informed consent form.*
•2.Diagnosed with drug refractory symptomatic persistent atrial fibrillation lasting longer than 7 days but less than or equal to 12 months
•3.Indicated for AF ablation for symptomatic persistent atrial fibrillation according to the latest version of JCS/JHRS guidelines (at investigators discretion).
•4.Scheduled to undergo AF ablation for treatment of their persistent AF using QDOT MICRO catheter
•5.Age 18 years or older
•6.Able and willing to comply with all pre-, post- and follow-up testing and requirement as per hospital standard of care
•*When a legal representative of the subject signs the consent, his/her legally acceptable representative must have signed and dated the informed consent form.

•Subjects must not meet ANY of the following exclusion criteria to be eligible for enrollment into the study:
•1.Previous surgical or catheter ablation for atrial fibrillation.
•2.Presenting any contra-indication for the use of QDOT MICRO catheter, as indicated in the IFU
•3.Women of childbearing potential who are, or plan to become, pregnant during the study
•4.Not expected to participate in the study for 12-month follow up post-procedure.
•5.Currently enrolled or planning to participate in any interventional study
•6.Uncontrolled heart failure or New York Heart Association (NYHA) function class IV
•7.Life expectancy of less than 12 months

发起方

Goya Masahiko