Observational, multi-center, clinical device registry for US patients with a primary goal to observe the clinical outcomes in patients who are mapped with Volta Medical's VX1 or AF-Xplorer systems during AF ablation procedures.
indicated for AF ablation or
Who has received an AF-ablation with the past 24 months where VX1 was used or
Patients are receiving or received a catheter ablation procedure for AF according to current guidelines
Patients must be able and willing to provide written informed consent to participate in the clinical trial
Patients not indicated or were not indicated for catheter ablation according to current guidelines
Patients with AF secondary to an obvious reversible cause
Patients who are or may potentially be pregnant
Enrollment in an investigational study evaluating another non-VX1 investigational device, biologic, or drug
Adult patients indicated for ablation for atrial fibrillation
Cohort
Prospective
AF Ablation
DevicePercutaneous, catheter-based ablation of atrial fibrillation
Primary Clinical Efficacy Outcome
Percentage of subjects free from clinically significant AF or atrial arrhythmia recurrences, after one or multiple ablation procedures, stratified by type of clinical workflow and ablation history.
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Volta Medical
Lead sponsor
Heart Rhythm Clinical and Research Solutions, LLC
Collaborator
