A Prospective, Multicenter, Investigation of the Adagio Cryoablation System in Patients with Atrial Fibrillation (AF). - CryoCure2

Adagio Medical Inc.0 个研究点目标入组 25 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•1. Patient is diagnosed with Paroxysmal (PAF), Persistent (PsAF) or Long-Standing Persistent atrial fibrillation for which an ablation procedure was deemed most appropriate therapy:
•Paroxysmal AF is defined as recurrent atrial fibrillation (AF) that terminates spontaneously within seven (7) days. Persistent AF is defined as: an episode lasting longer than seven (7) days, but less than one (1) year documented by consecutive ECG recordings of 100% AF greater than seven (7) days apart or an episode requiring electrical or pharmacological cardioversion after 48 hours of AF documented by continuous recording. Long-Standing Persistent AF is defined as continuous AF that lasts longer than one (1) year.
•2. Reported incidence of at least one (1) documented episode of symptomatic AF during the twelve (12) months preceding trial entry (should be documented by rhythm strip or ECG).
•3. Failure of at least one (1AAD for AF [class I or III, or AV nodal blocking agents such as beta blockers (BB) and calcium channel blockers (CCB)] as evidenced by recurrent symptomatic AF, or intolerable side effects due to AAD.

•1. Patient had any previous left atrial ablation.
•2. History of any valvular cardiac surgical procedure, atrial septal defect closure device; or left atrial appendage closure device.
•3. Coronary artery bypass grafting (CABG) procedure within the last 3 months.
•4. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months.
•5. Atrial clot/thrombus on imaging such as on a trans-esophageal echocardiogram (TEE) performed within 48 hours of the procedure if deemed appropriate by the investigator.
•6. History of a documented thromboembolic event within the past one (1) year.

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