FIRM Ablation Versus Pulmonary Vein Isolation for the Treatment of Paroxysmal Atrial Fibrillation (PAF)

Study Overview
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Brief Summary
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The study is designed as a prospective, multicenter, single-blind, randomized study to assess the safety and effectiveness of FIRM-guided radiofrequency (RF) ablation procedures for the treatment of symptomatic paroxysmal atrial fibrillation (PAF). The subjects will be blinded to study treatment for the duration of the study period.

Official Title
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Focal Impulse and Rotor Modulation (FIRM) Ablation Versus Pulmonary Vein Isolation (PVI) for the Treatment of Paroxysmal Atrial Fibrillation (PAF)

Conditions
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Paroxysmal Atrial Fibrillation

Intervention / Treatment
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* Procedure: FIRM-guided RF ablation
* Procedure: Conventional RF ablation


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Experiencing at least two (2) documented episodes of paroxysmal atrial fibrillation in the last 3 months preceding study entry with clinical indication for atrial fibrillation (AF) ablation per guidelines. At least one episode should be documented by rhythm strip or ECG. Indicated for AF ablation according to current European Heart Rhythm Association (EHRA) guidelines. Prescribed with oral anticoagulation therapy, in indicated patients per the latest EHRA guidelines. Willingness and able to remain on anti-coagulation therapy as per the latest EHRA guidelines. Left atrial diameter < 5.5 cm as measured and image ((computed tomography (CT)/ transesophageal echocardiogram (TEE)/ transthoracic echocardiogram (TTE)/ magnetic resonance imaging (MRI) or intracardiac echocardiography (ICE)) documented within previous six months up to pre-procedure. Sustained AF (>5 min uninterrupted) during the electrophysiology procedure. If the subject is not experiencing spontaneous, sustained AF, it may be induced by burst pacing (typically from the coronary sinus) with or without isoproterenol infusion in conventional clinical fashion. Key Exclusion Criteria: New York Heart Association heart failure (NYHA) Class III - IV. Ejection fraction < 40% (within previous six months). History of myocardial infarction (MI) within the past three months. Any concomitant arrhythmia or therapy that could interfere with the interpretation of the results from this study. Atrial septal defect (ASD) closure device, left atrial appendage (LAA) closure device, prosthetic mitral or tricuspid valve, or permanent pacemaker. Any previous AF catheter ablation. History of prior cardioversion for AF lasting > 48 hours. Continuous AF episode lasting > 7 days immediately prior to the procedure without a sinus rhythm.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FIRM-only<br>Subjects in this arm will be treated with FIRM-guided RF ablation without pulmonary vein isolation (PVI). | Procedure: FIRM-guided RF ablation<br> <br> |
| Active Comparator: Conventional<br>Subjects in this arm will undergo conventional radio frequency (RF) ablation with confirmation of PVI. | Procedure: Conventional RF ablation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Single-procedure Freedom From AF/AT Recurrence From 3-12 Months Post Index Ablation Procedure | Freedom from AF/AT recurrence is defined as no documented episodes of AF/AT > 30 seconds with conventional non-invasive monitoring. In the case of a cardiac implanted electronic device (CIED), freedom from AF recurrence is defined as no documented episodes of AF/AT > 30 seconds in a 72-hour window at the follow-up visits in addition to any symptomatic episodes with documented AF > 30 seconds. AT recurrence does not include episodes of cavotricuspid isthmus (CTI) dependent flutter. | 3 -12 months post study treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Freedom From Procedure-related Serious Adverse Events | Freedom from procedure-related serious adverse events within one year of the index procedure | Within 1 year post study treatment |