HD Mapping of Atrial Fibrillation in Asia Pacific

Study Overview
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Brief Summary
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The aim of this study is to quantify and characterize the outcomes of radiofrequency (RF) ablation after, and the utility of, electroanatomical mapping with the market-released HD mapping catheters Inquiry™ AFocusII™ Double Loop and Advisor™ HD Grid, Sensor Enabled™ with the EnSite Cardiac Mapping System and the EnSite Automap module in subjects with AF in the real-world environment of the Asian population.

Official Title
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HD Mapping Observational Study - Asia Pacific

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: Subject must provide written informed consent for study participation and willing and able to comply with the protocol described evaluations and follow up schedule Subject must be over 18 years of age. (In Japan, the subject must be of 20 years of age or older) Subject is diagnosed with AF as defined by: Documented symptomatic paroxysmal AF defined as AF that terminates spontaneously or with intervention within 7 days of onset Documented symptomatic persistent AF defined as continuous atrial fibrillation that is sustained beyond 7 days but less than 12 months Subject is indicated for cardiac electroanatomical mapping and RF ablation procedure to treat AF Subject is planned to have electroanatomical mapping performed with the HD mapping catheters under investigation Exclusion Criteria: Previous ablation or surgery in the left atria Implanted left atrial appendage occluder Implanted mitral or tricuspid valve replacement Implanted cardiac defibrillator (ICD) Participation in another clinical investigation that may confound the results of this study Pregnant or nursing Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results. Life expectancy less than 12 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Inquiry™ AFocusII™ Double Loop<br>The Inquiry™ AFocus™ catheters are for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiological studies. The Inquiry™ AFocus™ catheters are for use in mapping atrial regions of the heart. | Device: Catheter ablation<br>* Inquiry AFocusII Double Loop and Advisor HD Grid, Sensor Enabled<br>|
| Advisor™ HD Grid, Sensor Enabled™<br>The Advisor™ HD Grid Mapping Catheter, Sensor Enabled™, is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart with recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. | Device: Catheter ablation<br>* Inquiry AFocusII Double Loop and Advisor HD Grid, Sensor Enabled<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute- and long-term success rate of RF ablation after electroanatomical mapping with HD mapping catheters. | The rate of acute success defined as the proportion of subjects who receive HD mapping and RF energy delivery resulting in acute termination of clinical arrhythmia, defined by termination to SR (or AT if being treated for PersAF) or non-inducibility of clinical arrhythmia after ablation (cardioversion allowed prior to inducibility attempt). The rate of long-term success defined as the proportion of subjects who receive HD mapping and RF energy delivery with pre-defined procedural endpoints: AF freedom from all atrial arrhythmias (AF/AFL/AT) greater than 30 seconds (as documented by 24-hr Holter at 12-month follow-up) and on or off class I/III antiarrhythmic drug (AAD). AF freedom from all atrial arrhythmias (AF/AFL/AT) greater than 30 seconds (as documented by 24-hr Holter at 12-month follow-up) and off all class I/III AADs. | 12-months post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Procedure Time | Defined as time from initial catheter insertion to final catheter removal. | During Procedure | 
| Radiofrequency (RF) Time | Defined as duration of time RF energy is delivered | During Procedure | 
| Fluoroscopy time | Defined as total time subject is exposed to fluoroscopy | During Procedure | 
| Mapping time associated with mapping arrhythmia | Defined as the total cumulative mapping time and mapping time for the creation of each map (including any new or retrospective map created with Manual, AutoMap, and TurboMap mapping) | During Procedure | 
| Number of mapping points collected | Defined as total number of mapping points collected for the creation of each map | During Procedure | 
| Number of mapping points used | Defined as the total number of mapping points used in each map | During Procedure | 
| Number of used mapping points per minute | Defined as the total number of mapping points used divided by the relative mapping time | During Procedure | 
| Substrate characteristics identified | For each type of arrhythmogenic substrate this will be defined as the frequency of substrate type identified in cases that attempted to identify the specific substrate | During Procedure | 
| Ablation strategy(s) used | Defined by both the type of map used to define ablation strategy and the frequency each ablation strategy/target was used by physicians | During Procedure |