Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation With FIRM Guided Procedures

Study Overview
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Brief Summary
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A prospective, multicenter, randomized study to assess the safety and effectiveness of FIRM-guided procedures in conventional redo RF ablation procedures for the treatment of persistent and paroxysmal atrial fibrillation.

Detailed Description
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The hypothesis of this study was that Focal Impulse and Rotor Modulation (FIRM) guided procedures will eliminate the source of clinical arrhythmias in subjects with clinical indications for repeat AF ablation procedures. This study is a prospective, multicenter, randomized, controlled study to assess the safety and effectiveness of FIRM procedures followed by ablation including pulmonary vein isolation versus a standard conventional procedure including pulmonary vein isolation for the redo-treatment of persistent or paroxysmal atrial fibrillation after one failed previous pulmonary vein isolation.

Official Title
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Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation With Focal Impulse and Rotor Modulation Guided Procedures (REDO-FIRM)

Conditions
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Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation

Intervention / Treatment
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* Procedure: Standard PVI
* Procedure: FIRM-Guided Procedure and PVI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Experiencing at least one (1) documented episode of spontaneous persistent or paroxysmal atrial fibrillation during the last 3 months by rhythm strip/ECG. One (1) previous AF ablation (PVI-only - any technology) after Jan-01-2013, but NOT within the last 3 months. Left atrial diameter < 6.0 cm via transthoracic echo or transesophageal echo; or <6.5 cm via CT or MRI with 6 months prior to the procedure. Sustained spontaneous or induced AF (>5 min uninterrupted). Exclusion Criteria: Presence of structural heart disease with clinical significance NYHA Class IV Ejection fraction < 35% Previous AF ablation within the last 3 months ASD closure device, LAA closure device, prosthetic mitral or tricuspid valve, or permanent pacemaker. History of myocardial infarction (MI) within the past three (3) months Atrial clot/thrombus noted within 72 hours of the procedure

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard PVI<br>Standard catheter ablation including pulmonary vein isolation (PVI) procedure. | Procedure: Standard PVI<br>* Standard PVI procedure without FIRMap.<br>* Other names: Atrial fibrillation Mapping;|
| Experimental: FIRM-guided Procedure and PVI<br>FIRM-guided procedure followed by PVI. | Procedure: FIRM-Guided Procedure and PVI<br> <br> * Other names: FIRMap;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from atrial fibrillation atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) recurrence at 12 months post procedure. | Single procedure freedom from recurrence from 3-12 months post procedure | 12 months post procedure | 
| Freedom from serious adverse events related to the procedure | Freedom from any procedure-related serious adverse event from 0-10 days post procedure | 10-day post procedure | 
| Freedom from serious adverse events related to the procedure | Freedom from any procedure-related serious adverse event from 0-12 months post procedure | 12-month post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FIRMap, Rotor, FIRM-guided procedure