Advisor HD Grid Observational Study

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 Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (hereafter called HD Grid) and EnSite Precision™ Cardiac Mapping System (SV 2.2 or higher, hereafter called EnSite Precision) with HD Wave Vmax voltage mapping (hereafter called HD Wave) in subjects with PersAF or VT in real-world clinical settings.

Official Title
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Advisor HD Grid Observational Study

Conditions
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Persistent Atrial Fibrillation, Ventricular Tachycardia

Intervention / Treatment
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* Device: Advisor HD Grid Mapping Catheter, Sensor Enabled


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Subject must provide written informed consent for study participation and willing and able to comply with the protocol described evaluations and follow up schedule 2. Over 18 years of age 3. Indicated for cardiac electroanatomical mapping and RF ablation procedure to treat PersAF or VT 4. Subject is diagnosed with either PersAF OR VT as defined by: a. Persistent AF: i. Documented symptomatic persistent AF defined as continuous atrial fibrillation that is sustained beyond 7 days but less than 12 months b. VT: i. Sustained monomorphic ventricular tachycardia with record of VT event within last 6 months and history of prior myocardial infarction Exclusion Criteria: Life expectancy less than 12 months Women who are pregnant or nursing Known intracardiac thrombus or myxoma verified within 48 hours of index ablation procedure Myocardial infarction (MI) or unstable angina, or previous cardiac surgery within 60 days of index ablation procedure Percutaneous coronary intervention (PCI) within 30 days of index ablation procedure Documented cerebroembolic event within the past 12 months (365 days) History of valve repair, presence of a prosthetic valve, or severe mitral regurgitation thought to require valve replacement or repair within 12 months Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days) Current acute illness or active systemic infection or sepsis Currently enrolled in another clinical study that could confound the results of this study Any cause for contraindication to ablation procedure or systemic anticoagulation 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 study or to comply with follow-up requirements, or impact the scientific soundness of the clinical study results. Vulnerable patient or individuals whose willingness to volunteer in a study, in the judgement of investigator or public authorities, could be unduly influenced by lack of or loss of autonomy Indication-specific exclusion criteria including: a. PersAF: i. PersAF felt to be secondary to electrolyte imbalance, uncontrolled thyroid disease, or reversible or non-cardiac cause. ii. LAD > 55 mm (parasternal long axis view) iii. LVEF < 40% iv. Uncontrolled heart failure or NYHA function class III or IV v. Presence of implanted ICD/CRT-D. b. VT: i. VT/VF thought to be from channelopathies ii. Active ischemia or other reversible cause of VT iii. Incessant VT at time of procedure iv. Implanted with a ventricular assist device (VAD) (e.g. TandemHeart) v. Chronic NYHA Class IV heart failure vi. Ejection fraction < 15% -

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

| Intervention/Treatment |
| --- |
|Device: Advisor HD Grid Mapping Catheter, Sensor Enabled|The Advisor™ HD Grid Mapping Catheter, Sensor Enabled™, is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To quantify and characterize the acute- and long-term success rate of RF ablation after electroanatomical mapping with HD Grid and Ensite Precision with HD Wave in subjects with PersAF or VT. | The rate of acute success is defined as the proportion of subjects who receive HD Grid 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). For PersAF, the rate of long-term success rate is defined as the proportion of subjects who receive HD Grid mapping and RF energy delivery and have had freedom from all atrial arrhythmias (AF/AFL/AT) greater than 30 seconds (as documented by 48-hr Holter at 12-month follow-up) and a change in class I/III antiarrhythmic drug (AAD) use. For VT, the rate of long-term success is defined as the proportion of subjects who receive HD Grid mapping and RF energy delivery and have had freedom from reoccurrence of sustained monomorphic VT and a change in class I/III AAD use at 6-month follow-up. | 6 months (VT) 12 months (Persistent AF) | 

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 Time | Defined as duration of time RF energy is delivered | During Procedure | 
| Fluoroscopy Time | Defined as total time subject is exposed to fluorscopy | 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 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 | 
| Role of HD Wave map relative to along-the-spline map in ablation strategy decision. | Assessed by physician survey comparing maps generated with HD Wave electrode configuration to along-the-spline electrode configurations. | During Procedure | 
| Maneuverability of HD Grid Catheter | Defined as the ability to maneuver the HD Grid to each specified anatomic location if attempted, the ability to contact cardiac tissue, and the incidence of induced ectopic beats during maneuvering. | During Procedure | 
| HD Grid electrogram quality relative to ablation catheter electrograms | Defined as the proportion of electrograms collected with HD Grid that have better quality/less noise than electrograms collected with the ablation catheter at the same cardiac location as assessed by physician survey. | During Procedure |