Randomized Evaluation of Atrial Fibrillation Treatment With Focal Impulse and Rotor Modulation Guided Procedures

Study Overview
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Brief Summary
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The study is a prospective, multicenter, randomized study to assess the safety and effectiveness of FIRM procedures followed by conventional ablation including PVI versus a standard PVI procedure for the treatment of persistent atrial fibrillation (AF).

Official Title
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Randomized Evaluation of Atrial Fibrillation Treatment With Focal Impulse and Rotor Modulation Guided Procedures (REAFFIRM)

Conditions
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Persistent Atrial Fibrillation

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


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: At least two (2) documented episodes of persistent atrial fibrillation during prior 3 months Refractory, intolerant, or contraindicated to Class I or III anti-arrhythmic medications Left atrial diameter < 6.0 cm Key Exclusion Criteria: Previous AF Ablation Presence of structural heart disease New York Heart Association (NYHA) Class IV. Ejection fraction < 35%. History of myocardial infarction (MI) within the past three months.

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 Ablation<br>Standard catheter ablation including pulmonary vein isolation (PVI) procedure for the treatment of persistent AF. | Procedure: Standard PVI Ablation<br>* Standard PVI procedure without FIRMap.<br>* Other names: Mapping;|
| Experimental: FIRM-guided Procedure and PVI<br>FIRM-guided procedure followed by standard catheter ablation including PVI. | Procedure: FIRM-Guided Procedure and PVI<br>* FIRM-guided procedure followed by conventional ablation including PVI.<br>* Other names: FIRMap;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom From Procedure-related Serious Adverse Events (SAEs) Within 7-10 Days of the Procedure |  | Within 7-10 days of the Procedure | 
| Single-procedure Freedom From AF/AT Recurrence at 3 Month Post Index Procedure. |  | 3-month follow up | 
| Single-procedure Freedom From AF/AT Recurrence at 3 to 12 Months Post Index Procedure. |  | 3-12 months post study treatment | 
| Freedom From Procedure-related SAEs (Including Those Related to Any Repeat Procedures) Within 12-months of the Initial Procedure |  | 3 to 12 months post study treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the Acute Effectiveness of FIRM-guided Procedures in Eliminating the Source of Arrhythmia as Shown by: No Evidence of the Source in FIRMap Post-op, OR Reduction of Electrogram Amplitude to < 0.2 Millivolts |  | Immediately post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Focal Impulse and Rotor Modulation Mapping Catheter (FIRMap), Rotor, FIRM-guided procedure, REAFFIRM