RESOLVE-AF: Clinical Evaluation of the Ablacath™ Mapping Catheter and Ablamap® System Utilizing Electrographic Flow (EGF) Mapping to Resolve Extra-PV Sources of Atrial Fibrillation and Guide Ablation Therapy.

Study Overview
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Brief Summary
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Demonstrate the safety and effectiveness of the Ablacath™ Mapping Catheter and Ablamap® System in patients with all types of atrial fibrillation (AF) including paroxysmal or persistent or long-standing persistent, undergoing and De Novo or Redo procedures. Phenotype patients and demonstrate the prognostication power of Electrographic Flow (EGF®) maps among all subjects using 12-month follow-up outcomes following EGF-guided mapping and ablation.

Detailed Description
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Subjects with all types of AF who are candidates for catheter ablation of their AF. The study will enroll up to 400 subjects in 25 centers globally.

Official Title
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Prospective, Single Arm, Multi-center, Clinical Evaluation of the Ablacath™ Mapping Catheter and Ablamap® System Utilizing Electrographic Flow (EGF) Mapping to Resolve Extra-pulmonary Vein Sources of Atrial Fibrillation and Guide Ablation Therapy.

Conditions
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Atrial Fibrillation, Atrial Fibrillation, Persistent, Atrial Fibrillation Paroxysmal, Arrhythmia, Arrhythmias, Cardiac, Atrial Flutter, Atrial Fibrillation, Paroxysmal or Persistent, Atrial Arrhythmia, Atrial Tachycardia

Intervention / Treatment
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* Device: Ablacath™ Mapping Catheter, Ablacath™ Mapping Catheter Accessory Cables, Ablamap® System inclusive of Amplifier, Monitor/Workstation with installed Ablamap® Software


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Suitable candidate for intra-cardiac mapping and ablation of atrial arrhythmias including atrial fibrillation, atrial flutter and/or atrial tachycardia Above eighteen (18) years of age or of legal age to give informed consent specific to state and national law Left atrial (LA) diameter ≤ 5.5 cm or LA volume index ≤ 50 mL/m2 (use whichever measure is available or if both available, use the lesser of the two to qualify) Exclusion Criteria: De Novo paroxysmal AF AF from a reversible cause (e.g., surgery, hyperthyroidism, sarcoidosis, or pericarditis, etc.) Cardiac surgery or intervention within the past 90 days (e.g. percutaneous coronary intervention, ablation for ventricular arrhythmias, left atrial appendage occlusion devices, atrial septal defect closure devices, transcatheter aortic valve replacement) Presence of transvenous pacing or defibrillator leads or an atrial leadless pacemaker Myocardial infarction within the past 90 days Severe valvular disease or prosthetic valve(s) Contraindication to therapeutic anticoagulation Decompensated heart failure or New York Heart Association (NYHA) Functional Class IV Positive pregnancy test Any other contraindication to an intracardiac mapping and ablation of atrial arrhythmias Enrollment in another investigational study evaluating another device, biologic or drug

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Abacath Mapping Catheter/Ablamap System<br> | Device: Ablacath™ Mapping Catheter, Ablacath™ Mapping Catheter Accessory Cables, Ablamap® System inclusive of Amplifier, Monitor/Workstation with installed Ablamap® Software<br>* EGF-Mapping and EGF-Guided Ablation of AF Sources<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from documented AF episodes lasting > 30 seconds (with or without AAD) following the index procedure through 12-months | Evaluated by assessing rate of subjects free from AF following index procedure through 12 months with or without AAD | 12 months | 
| Freedom from a composite of serious adverse events (SAEs) occurring within 7 days from the index procedure | Evaluated by assessing combined rate of SAE composite as adjudicated by a CEC for relatedness to device or procedure | 7 days | 
| Demonstrate the predictive value of EGF phenotype for ablation outcome | Evaluated through the comparison ablation outcomes between redo and de novo AF subjects | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from a composite of SAE occurring within 30 days from post-index ablation procedure | Evaluated by assessing combined rate of SAE composite as adjudicated by a CEC for relatedness to device or procedure | 30 days | 
| Overall reduction in burden of AF for subset of patients with implantable loop recorder | Evaluation of patient freedom from AF | 12 months | 
| Overall procedure time, fluoro time, total EGF-guided mapping time, total EGF-guided ablation time | Evaluation of index or repeat procedure times | Index or Repeat Procedure |