The primary purpose of this registry is to obtain real-world clinical experience of Paroxysmal (PAF) and Persistent (PsAF) Atrial Fibrillation ablation radiofrequency (RF) technologies. Data from the registry will be used to assess clinical outcomes, including procedural efficiency, safety, and long-term, effectiveness of catheter ablation with novel RF technologies in PAF and PsAF patients.
Symptomatic Paroxysmal (AF episode terminate spontaneously within 7 days) or Persistent (AF sustained beyond 7 days) who, in the opinion of the investigator, are candidates for ablation for AF
18 years of age or older
De Novo ablation procedure unless it is a repeat for a patient whose index procedure is also in the registry
Able and willing to participate in baseline and follow up evaluations for the full length of the registry
Enrolled in an investigational drug or device clinical trial, or any trial that dictates the treatment plan
Long-standing persistent AF (AF greater than one year's duration)
Having a repeat ablation, unless the subject's index ablation procedure is also included in the registry
In the opinion of the investigator, any known contraindication to an ablation procedure
Study population consists of adults age 18 years or older with symptomatic Paroxysmal and Persistent Atrial Fibrillation who are candidates for ablation.
Cohort
Other
Catheter ablation
DeviceAblation RF technologies (e.g., THERMOCOOL SMARTTOUCH®, THERMOCOOL SMARTTOUCH® SF).
Effectiveness at 90 days
Freedom from atrial arrhythmia recurrence at 90 days post procedure.
Effectiveness at 12 months
Freedom from atrial arrhythmia recurrence at 12 months post procedure.
Long-term Safety
Adverse events from post-procedure through the 12-month office visit date
AF recurrence
Recurrence seen during monitoring with Dual/ CRT Pacer or ICD; Event Monitor; LinQ; Holter; EKG; TTE
Post-procedure arrhythmia treatments
Treatments for AF post-procedure
AF related symptoms
Presence of: weakness, fluttering, SOB, fatigue, dizziness, decrease in exercise tolerance, chest pain/pressure, heart racing/palpitations, and other (yes/no)
AAD Usage
Antiarrhythmic drug use (and type) post procedure and 12 months
Click on the lead sponsor to view all of their trials.
Heart Rhythm Clinical and Research Solutions, LLC
Lead sponsor
Biosense Webster, Inc.
Collaborator
