Evaluation of the Phased Radio Frequency Ablation System

Study Overview
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Brief Summary
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VICTORY AF is an IDE, prospective global, multi-center, single arm, controlled, unblinded, investigational clinical study. The purpose of this clinical study is to evaluate the risk of procedure and/or device related strokes in subjects with persistent or long-standing persistent atrial fibrillation (AF) undergoing ablation with the Phased RF System.

Official Title
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Evaluation of Multielectrode Phased RF Technology in Persistent Atrial Fibrillation

Conditions
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Persistent Atrial Fibrillation

Intervention / Treatment
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* Device: Medtronic Phased RF Ablation System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of symptomatic persistent or long-standing persistent atrial fibrillation Failure of at least one anti-arrhythmic drug Exclusion Criteria: Structural heart disease Prior ablation in left atrium for AF Known sensitivities (or allergy) to heparin, warfarin, contrast media Contraindicated for MRI Invasive cardiovascular procedure performed or planned within 3 month period of ablation procedure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Interventional Model Description: Treatment with Phased RF Ablation System
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ablation<br>Phased RF ablation | Device: Medtronic Phased RF Ablation System<br>* Phased RF ablation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Procedure and/or Device Related Stroke | A stroke with with a symptom onset date within 30 days of an ablation procedure where at least one Phased RF ablation catheter was deployed into the left atrium considered related to the procedure and/or the investigational device by the independent clinical events committee | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-month Post-procedure Effectiveness | For a participant, the 6-month effectiveness defined as meeting all of the following criteria: (1) acute procedural success, (2) greater than 90% reduction in atrial fibrillation/atrial flutter episodes lasting longer than 10 minutes as measured by 48-hour ambulatory ECG, (3) No amiodarone use for 90 days and no class I or class III antiarrhythmic drugs for at least 60 days prior to 6-month ambulatory ECG, and (4) free from direct current cardioversion for at least 60 days prior to the 6-month ambulatory ECG | 6 months | 
| Number of Participants With Acute Procedural Success | Acute procedural success defined as: (1) Only Phased RF ablation catheters used in the left atrium, (2) all targeted pulmonary veins isolated, (3) all complex fractionated atrial electrograms and high frequency intracardiac electrogram amplitudes were mapped and ablated, and (4) sinus rhythm was restored at the end of the ablation procedure (with or without cardioversion) | 30 minutes | 
| Number of Participants With Pulmonary Vein Stenosis | Greater than 70 percent reduction in the luminal diameter in any one or more of the pulmonary veins following a Phased RF ablation procedure | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ablation, atrial fibrillation, Radio frequency