NL-OMON47281招募中不适用
AMPLATZER* Amulet* Left Atrial Appendage (LAA) Occluder <br>Randomized Controlled Trial <br> - AMULET IDE
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
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 64（—）
入选标准
- •1. 18 years of age or older
- •2. Documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation and the
- •patient has not been diagnosed with rheumatic mitral valvular heart disease
- •3. At high risk of stroke or systemic embolism defined as CHADS2 score > 2 or a CHA2DS2-VASc
- •score of > 3
- •4. Has an appropriate rationale to seek an alternative to warfarin or other anticoagulant medication
- •5. Deemed by investigator to be suitable for short term warfarin therapy but deemed unable to take
- •long term anticoagulation, following the conclusion of shared decision making (see inclusion
- •criteria #6)
- •6. Deemed suitable for LAA closure by a multidisciplinary team of medical professionals (including
- •an independent non-interventional physician) involved in the formal and shared decision-making
- •process, and by use of an evidence-based decision tool on oral anticoagulation (final
- •determination must be documented in the subject*s medical record)
- •7. Able to comply with the required medication regime post-device implant
- •8. Able to understand and is willing to provide written informed consent to participate in the trial
- •9. Able and willing to return for required follow-up visits and examinations
排除标准
- •1. Requires long-term oral anticoagulation therapy for a condition other than atrial fibrillation
- •2. Contraindicated for or allergic to aspirin, clopidogrel, or warfarin use
- •3. Indicated for chronic P2Y12 platelet therapy inhibitor
- •4. Is considered at high risk for general anesthesia, in the opinion of the investigator, and/or based on past adverse reaction(s) requiring medical intervention or which resulted in prolongation of hospital stay (criterion is only applicable where general anesthesia is planned for the study procedure)
- •5. Has undergone atrial septal defect (ASD) repair or has an ASD closure device present
- •6. Has undergone patent foramen ovale (PFO) repair or has a PFO closure device implanted
- •7. Implanted with a mechanical valve prosthesis
- •8. Has any of the customary contraindications for a percutaneous catheterization procedure (e.g.
- •subject is too small to accommodate the TEE/TOE probe or required catheters, or subject has
- •active infection or bleeding disorder)
- •9. Stroke or transient ischemic attack (TIA) within 90 days prior to randomization or implant
- •procedure (as applicable)
- •10. Underwent any cardiac or non-cardiac intervention or surgery within 30 days prior to
- •randomization, or intervention or surgery is planned within 60 days after implant procedure (e.g.
- •cardioversion, ablation, cataract surgery, etc.)
- •11. Myocardial infarction (MI) within 90 days prior to randomization
- •12. New York Heart Association Class IV Congestive Heart Failure
- •13. Left ventricular ejection Fraction (LVEF) <30%
- •14. Symptomatic carotid disease (defined as >50% stenosis 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%
- •15. Reversible cause of AF (i.e. secondary to thyroid disorders, acute alcohol intoxication, trauma,
- •recent major surgical procedures)
- •16. History of idiopathic or recurrent venous thromboembolism
- •17. Left atrial appendage is obliterated or surgically ligated
- •18. Thrombocytopenia or anemia requiring transfusions
- •19. Hypersensitivity to any portion of the device material or individual components of either the Amulet or Boston Scientific LAA closure device (e.g. nickel allergy)
- •20. Actively enrolled or plans to enroll in a concurrent clinical study in which the active treatment arm may confound the results of this trial
- •21. Subject is pregnant or pregnancy is planned during the course of the investigation
- •22. Active endocarditis or other infection producing bacteremia
- •23. Subject has had a transient case of AF (i.e. never previously detected, provoked/induced by surgical or catheter manipulations, etc.)
- •24. Subjects with severe renal failure (estimated glomerular filtration rate <30 ml/min/1.73m2)
- •25. Subject whose life expectancy is less than 2 years
- •26. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator*s opinion, could limit the subject*s ability to participate in the clinical trial or to comply with follow up requirements, or impact the scientific soundness of the clinical trial results.;To participate in the trial, subjects must not meet any of the following echocardiographic exclusion criteria:
- •1. Intracardi
研究者
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