Clinical trial of atrial fibrillation patients comparing left atrial appendage occlusion therapy to non-vitamin K antagonist oral anticoagulants - CATALYST

Kozuma Ken0 个研究点目标入组 120 人开始时间: 2022年6月9日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1.Documented paroxysmal, persistent, or permanent non-valvular AF (documentation must include an electrocardiogram, Holter, or event recorder)
•2.At high risk of stroke or systemic embolism, defined as a CHA2DS2-VASc score of more than 3
•3.Eligible for long-term NOAC therapy
•4.Able to comply with the required NOAC medication regimen if randomized to the Control Group
•5.Able to comply with the required medication regimen post-device implant if subject is randomized to the Device Group or subject is a Roll-in

•1.Requires long-term OAC therapy for a condition other than AF
•2.Planned cardiac intervention or surgery, which is invasive or requires sedation or anesthesia, within 3 months following randomization, other than study-related procedures such as LAAO and cardiac imaging (if applicable)
•3.Known contraindication to, or allergic to, aspirin, clopidogrel, or OAC medication use
•4.Indicated for P2Y12 platelet inhibitor for > 1 year post-randomization
•5.In the opinion of the investigator, is considered at high risk for general anesthesia and general anesthesia is planned for the study procedure
•6.Has undergone atrial septal defect (ASD) repair or has an ASD closure device present
•7.Has undergone patent foramen ovale (PFO) repair or has a PFO closure device implanted
•8.Is implanted with a mechanical valve prosthesis
•9.Is implanted with an inferior vena cava filter
•10.History of rheumatic or congenital mitral valve heart disease

发起方

Kozuma Ken