tilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Recurrent Atrial Fibrillation Following a Failed AF Ablation (RECOVER AF) - RECOVER AF (CLP-AF-004) 3694/0003

Acutus Medical, Inc.0 个研究点目标入组 60 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

暂无简介。

•IC 1 Male or female eighteen (18) years of age or older
•IC 2 Currently scheduled for a repeat endocardial ablation of AF
•IC 3 Willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full length of the study
•IC 4 Willingness and ability to give informed consent

•EC 1 In the opinion of the Investigator, any known contraindication to a left-atrial ablation or concerns for left-atrial thrombus
•EC 2 No more than two (2) previous left-atrial ablations
•EC 3 Atrial arrhythmias secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause
•EC 4 Structural heart disease or implanted devices as described below:
•a. An implanted pacemaker or ICD
•b. Previous cardiac surgery, ventriculotomy, or atriotomy (excluding atriotomy for CABG)
•c. Previous cardiac valvular surgical or percutaneous procedure, or prosthetic valve
•d. Interatrial baffle, closure device, patch, or PFO occluder
•e. Presence of a left atrial appendage occlusion device
•f. Unstable angina or ongoing myocardial ischemia
•EC 5 History of blood clotting or bleeding disease
•EC 6 Pregnant or lactating (current or anticipated during study follow up)
•EC 7 Current enrollment in any study protocol sponsored by Acutus Medical or any other study that may impact the results of RECOVER AF
•EC 8 Any other condition that, in the judgment of the investigator, makes the patient a poor candidate for this procedure, the study, or compliance with the protocol (includes vulnerable patient
•population, mental illness, addictive disease, terminal illness with a life expectancy of less than two years, extensive travel away from the research center, etc.)

发起方