NL-OMON54346招募中不适用
Catalyst Trial: Clinical trial of atrial fibrillation patients comparing left atrial appendage occlusion therapy to non-vitamin K antagonist oral anticoagulants - Catalyst
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 26
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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 >= 3 for women and >= for men
- •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
- •6. Able to understand, and is willing to provide, written informed consent to
- •participate in the trial,
- •prior to any clinical investigation related procedure or assessment
- •7. 18 years of age or older, or the age of legal consent
- •8. Able and willing to return for required follow-up visits and assessments
排除标准
- •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
- •7. Has undergone patent foramen ovale (PFO) repair or has a PFO closure device
- •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
- •11. Has any of the customary contraindications for a percutaneous
- •catheterization procedure
- •(e.g. subject is too small to accommodate the ICE probe (if planned) or
- •required catheters,
- •or subject has active infection or bleeding disorder)
- •12. Customary contraindications for TEE/TOE (e.g., presence of esophageal
- •varices, esophageal
- •stricture, or history of esophageal cancer)
- •13. Experienced stroke or transient ischemic attack (TIA) within 90 days prior
- •to randomization or
- •implant procedure (as applicable)
- •14. Underwent any cardiac or non-cardiac intervention or surgery within 30 days
- •randomization
- •15. Underwent catheter ablation for AF or atrial flutter within 60 days prior
- •to randomization
- •16. Experienced myocardial infarction within 90 days prior to randomization
- •17. New York Heart Association Class IV Congestive Heart Failure
- •18. Left ventricular ejection fraction <= 30% (per most recent assessment)
- •19. Symptomatic carotid disease (defined as > 50% lumen diameter narrowing on
- •or TCD with symptoms of ipsilateral transient or visual TIA evidenced by
- •amaurosis fugax,
- •ipsilateral hemispheric TIAs or ipsilateral stroke); if subject has a
- •history of carotid stent or
- •endarterectomy the subject is eligible if there is < 50% lumen diameter
- •20. Has known intracranial atherosclerosis and/or intracranial small vessel
- •disease (defined
- •as 6 points on the Fazekas Scale)
- •21. Reversible cause of AF (i.e., secondary to thyroid disorders, acute alcohol
- •intoxication,
- •trauma, recent major surgical procedures)
- •22. History of idiopathic or recurrent venous thromboembolism
- •23. LAA is obliterated or surgically ligated
- •24. Thrombocytopenia (defined as < 50,000 platelets per microliter (<50 x 109
- 另有 12 项未显示
研究者
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