Randomized Evaluation of Atrial Fibrillation treatment with focal impulse and Rotor Modulation guided procedure ( REAFFIRM) - REAFFIRM

Abbott Electrophysiology0 个研究点目标入组 50 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•-1.Male or female 18 - 80 years of age.
•2.Experiencing at least two (2) documented episodes of persistent atrial fibrillation (including long standing persistent) during the 3 months preceding study entry with clinical indication for AF ablation per guidelines. At least one episode must be documented by rhythm strip or ECG.
•3.Refractory, contraindicated, or intolerant to Class I or III anti-arrhythmic medications. Drug doses must be therapeutic and stable.
•4.Oral anticoagulation required with either Novel Oral Anticoagulant (e.g. dabigatran, rivaroxaban, apixaban), Warfarin (therapeutic INR >= 2.0 for at least three weeks prior to randomization), or other similar standard-of-care oral anticoagulant therapy is required (aspirin is not considered similar) for those subjects who meet two or more of the following criteria:
•a.Age 65 years or older
•c.Coronary artery disease (CAD)
•d.Prior stroke or transient ischemic attack
•e.Congestive heart failure
•f.Hypertension with systolic>165 mm Hg
•5.Willingness and able to remain on anti-coagulation therapy for a minimum of 3 months post procedure for all subjects and at least 12 months post procedure if the patient has CHADS2 score >= 2.

•1.Presence of structural heart disease of clinical significance including:Coronary artery disease with either:
•oCoronary artery bypass surgery (CABG) within the last six months, or
•oStable/unstable angina or ongoing myocardial ischemia
•b.Congenital heart disease where either the underlying abnormality or its correction prohibits or increases the risk of ablation.
•2.NYHA Class IV.
•3.Ejection fraction < 35%.
•4.History of myocardial infarction (MI) within the past three months.
•5.Any concomitant arrhythmia or therapy that could interfere with the interpretation of the results from this study.
•6.ASD closure device, LAA closure device, prosthetic mitral or tricuspid valve and permanent pacemakers or defribrillator leads
•7.Untreatable allergy to contrast media.

发起方

Abbott Electrophysiology