Evaluate Reduction in Asymptomatic Cerebral Embolism - ERACE Feasibility study

Medtronic B.V.0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•Subject is at least 18 years old
•Subject has been diagnosed with atrial fibrillation (AF)
•Subject is indicated for a pulmonary vein ablation using PVAC
•Subject (or subject*s legally authorized representative) is able and willing to give informed consent

•Subject has permanent AF
•Subject has a left atrial thrombus detected on TEE
•Subject has had a prior left atrial ablation
•Subject has an intracardiac thrombus
•Subject is contraindicated for Warfarin (Coumadin)
•Subject has a cardiac valve prosthesis
•Subject has a significant congenital heart defect corrected or not (including atrial septal defects or pulmonary vein abnormalities but not including minor PFO)
•Subject has presence of any pulmonary vein stents
•Subject has presence of any pre-existing pulmonary vein stenosis
•Subject has had a cerebral ischemic event (strokes or TIAs) which occurred during the 6 month interval preceding the Consent Date
•Subject will undergo additional left atrial ablations with catheters other than a PVAC.
•Subject is a woman known to be pregnant
•Subject is unable or unwilling to participate with study procedures

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