High-Density (HD) Wave Mapping in Subjects With Atrial Fibrillation as a Predictor of Recurrence After a Single Ablation Procedure Using a PVI-Only Strategy

Study Overview
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Brief Summary
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The aim is to use the GRID to characterize the atrial substrate and develop a model for predicting recurrence rates after a single procedure using a PVI only approach and a contact catheter.

Detailed Description
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This clinical investigation is intended to characterize the left atrial substrate using the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ in an HD Wave configuration and correlate different factors with 12-month success after a single ablation procedure using a pulmonary vein isolation (PVI) approach without further substrate modification. This is a post-market, single-arm, multi-center, prospective interventional study of the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™. This study is aimed at determining correlations between pre-ablation mapping characteristics and outcomes after catheter ablation of atrial fibrillation. Approximately 300 subjects at up to 20 sites worldwide will be enrolled. Subjects will be followed until they complete their 12-month visit. Clinical Investigation visits will occur at Baseline (confirmation of eligibility), Index Procedure, 3 months, 6 months, and 12 months. Endpoints will be analyzed when all subjects have completed their 12-month follow up visits.

Official Title
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High-Density (HD) Wave Mapping in Subjects With Atrial Fibrillation as a Predictor of Recurrence After a Single Ablation Procedure Using a PVI-Only Strategy

Conditions
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Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Cardiac Arrhythmia

Intervention / Treatment
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* Procedure: A specific electrophysiology mapping protocol is applicable with the GRID catheter.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Documented atrial fibrillation with planned endocardial ablation procedure Age 18 years or older Able and willing to provide written informed consent prior to any clinical investigation related procedure Able and willing to complete all required study procedures through 12 months Exclusion Criteria: Long-standing persistent atrial fibrillation defined as continuous AF greater than 12 months in duration 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

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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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: All subjects enrolled will undergo the same mapping and ablation protocol.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Mapping protocol with GRID catheter<br>All patient will undergo a protocol required mapping protocol using the GRID catheter. | Procedure: A specific electrophysiology mapping protocol is applicable with the GRID catheter.<br>* The procedure will be done according to a standard ablation approach. During the electrophysiology study, additional mapping data will be collected to support the study endpoints using the GRID catheter.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| One-year success | Defined as freedom from atrial fibrillation, atrial flutter and atrial tachycardia after removal from the antiarrhythmic drug therapy as assesses from the end of the 3-month blanking period to 12 months following a single ablation procedure. Survival analysis will be conducted to analyze time-to-event variables. | 12 months |