Real-world Experience of Catheter Ablation for the Treatment of Paroxysmal and Persistent Atrial Fibrillation

Study Overview
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Brief Summary
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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.

Detailed Description
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The REAL AF Registry is an observational, prospective, multi-center, non-randomized registry designed to obtain real-world clinical experience of Paroxysmal and Persistent ablation RF technologies (e.g., THERMOCOOL SMARTTOUCH®, THERMOCOOL SMARTTOUCH® SF). Future new contact force technologies may be included as they become available in the market. Patient assessments will occur at the following time points: 1) pre-ablation, 2) procedure, 3) 10-12 weeks, 4) 6 months (monitor only) and 5) 1 year post ablation. The objective of this registry is to assess clinical outcomes, including procedural efficiency, safety, long-term, effectiveness of RF ablations in the treatment of patients with Paroxysmal or Persistent atrial fibrillation. The outcomes of the registry are: 1) long term effectiveness defined as freedom from atrial arrhythmia recurrence post 90 day blanking period, and 2) acute and late onset complications. Sites selected for this registry will already have the following pre and post procedure assessments as part of their standard of care: Patient assessments at the following time points: (1) pre-ablation or baseline, (2) procedure, (3) 10-12 weeks, (4) 6 months (monitor only) and (5) 1 year post ablation. Pre ablation/baseline assessment should include: TTE (within 6 months of procedure), CHADS2Vasc, sleep apnea, AAD status, OAC, Medical and Arrhythmia History 10-12 Week Follow-Up Office Visit: Physician evaluation, AAD status, OAC usage, repeat TTE, and Arrhythmia Reoccurrence and Treatment Assessment Monitoring: 96-hour continuous heart rhythm monitor scheduled at 6 months and 12 months post ablation, with an event monitor ordered as needed for symptomatic arrhythmias. 12 Month Follow up Office Visit: Physician evaluation, AF Type, AF Monitoring method, Sleep apnea, Post-procedure arrhythmia treatments, AF related symptoms and QOL improvement, AAD and OAC usage, CHA2DS2VASC and Arrhythmia Reoccurrence and Treatment Assessment

Official Title
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Real-world Experience of Catheter Ablation for the Treatment of Symptomatic ParoxysmaL and Persistent Atrial Fibrillation Using Novel CARTO Technologies: REAL AF Registry

Conditions
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Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation

Intervention / Treatment
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* Device: Catheter ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Willing and able to provide informed consent, if applicable Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with atrial fibrillation<br>Subjects with symptomatic PAF or PsAF who, in the opinion of the investigator, are candidates for ablation for AF, age 18 years or older, and are able and willing to comply with all pre-, post-, and follow-up testing and requirements. | Device: Catheter ablation<br>* Ablation RF technologies (e.g., THERMOCOOL SMARTTOUCH®, THERMOCOOL SMARTTOUCH® SF).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness at 90 days | Freedom from atrial arrhythmia recurrence at 90 days post procedure. | 90 days | 
| Effectiveness at 12 months | Freedom from atrial arrhythmia recurrence at 12 months post procedure. | 12 months | 
| Long-term Safety | Adverse events from post-procedure through the 12-month office visit date | Post-procedure, 3 months, and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AF recurrence | Recurrence seen during monitoring with Dual/ CRT Pacer or ICD; Event Monitor; LinQ; Holter; EKG; TTE | 12 months | 
| Post-procedure arrhythmia treatments | Treatments for AF post-procedure | 12 months | 
| AF related symptoms | Presence of: weakness, fluttering, SOB, fatigue, dizziness, decrease in exercise tolerance, chest pain/pressure, heart racing/palpitations, and other (yes/no) | 12 months | 
| AAD Usage | Antiarrhythmic drug use (and type) post procedure and 12 months | 12 months | 
| OAC usage | Oral anticoagulant use at 12 months and drug type | 12 months | 
| CHA2DS2VASC | An estimation of stroke risk for patients with Atrial Fibrillation. Composite score of: Age (<65= 0; 65-74=1; >75=2) + Sex (Female=1; Male=0) + Congestive Heart Failure (Yes =1; No=0) + Hypertension (Yes= 1; No= 0) + Stroke, Transient Ischemic Attack (TIA) or thromboembolism (Yes=2; No=0) + Vascular Disease (Yes=1; No=0) + Diabetes (Yes=1; No=0). Scores range from 0 to 9, with higher scores indicating greater risk for stroke. | 12 months | 
| Patient reported outcome | How do you feel now compared to pre-ablation? | 12 months |