CONVERGE - Epi/Endo Ablation For Treatment of Persistent Atrial Fibrillation(AF)

Study Overview
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Brief Summary
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This is a multi-center, open label, randomized pivotal study evaluating the safety and efficacy of the EPi-Sense-AF Guided Coagulation System for the treatment of persistent AF patients, refractory or intolerant to at least one Class I and/or III Anti Arrhythmic Drug (AAD).

Detailed Description
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The objective of this randomized pivotal study is to evaluate the safety and efficacy of the AtriCure EPi-Sense®-AF Guided Coagulation System with VisiTrax® for the treatment of symptomatic persistent Atrial Fibrillation (AF) patients, refractory or intolerant to at least one Class I or Class III anti-arrhythmic drug (AAD). 153 subjects from up to 27 US and 3 OUS sites. Randomized 2:1. The primary efficacy endpoint is success or failure to be AF/AT/AFL free absent class I and III AADs except for a previously failed or intolerant class I or III AAD with no increase in dosage following the 3-month blanking period through the 12-month post procedure follow-up visit. The primary safety endpoint is the incidence of major adverse events (MAEs) listed in the protocol for subjects undergoing the convergent procedure for the procedural to 30-day post procedure time period.

Official Title
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Convergence Of Epicardial And Endocardial Radiofrequency (RF) Ablation For The Treatment Of Symptomatic Persistent AF

Conditions
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Persistent Atrial Fibrillation

Intervention / Treatment
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* Device: AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax
* Device: Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years; < 80 years Left atrium < 6.0 cm Refractory or intolerant to one AAD (class I and/or III) Documentation of persistent AF Provided written informed consent Exclusion Criteria: Patients requiring concomitant surgery Left ventricular ejection fraction < 40% Pregnant or planning to become pregnant during study Co-morbid medical conditions that limit one year life expectancy Previous cardiac surgery History of pericarditis Previous cerebrovascular accident (CVA), excluding fully resolved transient Ischemic attack (TIA) Patients who have active infection or sepsis Patients with esophageal ulcers strictures and varices Patients with renal dysfunction who are not on dialysis Patients who are contraindicated for anticoagulants Patients who are being treated for ventricular arrhythmias Patients who have had a previous left atrial catheter ablation for AF Patients with existing Implantable Cardioverter-Defibrillator (ICDs) Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a study within 30 days prior to study enrollment Not competent to legally represent him or herself

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
Interventional Model Description: 2:1 randomized (Convergent Procedure versus standalone endocardial catheter ablation) multi-center pivotal clinical study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Convergent Procedure<br>Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment | Device: AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax<br>* Convergent Epicardial Endocardial Ablation Procedure<br>* Other names: Epicardial EPi-Sense-AF Guided Coagulation System combined with endocardial RF catheter ablation;Device: Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering<br>* Endocardial Catheter Ablation Procedure<br>|
| Active Comparator: Standalone Endocardial Catheter Ablation<br>Procedure/Surgery: Endocardial Catheter Ablation Treatment | Device: Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering<br>* Endocardial Catheter Ablation Procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Efficacy Endpoint - Number of Participants to Achieve Freedom From AF/AT/AFL. | This binary primary endpoint measures number of patients to achieve freedom from AF/AT/AFL absent class I and III AADs except for previously failed or intolerant I or III AAD with no increase in dosage following the 3-month blanking period through the 12 months post procedure follow-up visit will be compared between the two treatment groups using a chi-square test using a two-sided alpha of .05 to determine if superiority of the treatment arm is attained. | 12 Months | 
| Primary Safety Analysis | The primary safety analysis will measure the number of Major Adverse Events (MAE) collected from the start of the coagulation procedure to 30 days post procedure. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Safety Endpoint - Serious Adverse Events Through 12 Months Post-procedure. | The secondary safety endpoint for the study was the number of participants with serious adverse events (SAEs) in the study through the 12-months post-procedure. | 12 month | 
| Number of Patients With AF Burden Reduction of at Least 90% at 12 Months Compared to Baseline | AF Burden Reduction of at Least 90% at 12-Months (ITT Population): The first secondary effectiveness endpoint in the fixed-sequence testing was defined as at least 90% reduction in AF burden, absent of an increased dose or new class I/III AADs, at 12 months compared to baseline. | 12 Months | 
| AF Freedom Through 12 Months- Absent of an Increased Dose or New Class I/III AAD's. | Number of patients with AF Freedom through 12 Months (ITT Population) absent of an increased dose or new class I/III AAD's | 12 Months | 
| Number of Subjects With AF Burden Reduction of at Least 90% at 12 Months Relative to Baseline, Regardless of Class I/III AADs. | Number of subjects with AF freedom through 12 months achieved in the EPi-Sense group compared to subjects in the Catheter Ablation group. | 12 Months | 
| Change in Atrial Fibrillation Severity Scale (AFSS) | Change was calculated as the value at 12 months minus the value at baseline. The University of Toronto's Atrial Fibrillation Severity Scale (AFSS) is a composite score of overall subject-perceived severity, global well-being, atrial fibrillation frequency, and atrial fibrillation duration. The score ranges from 3 to 30, with higher scores indicating greater atrial fibrillation burden. | 12 months | 
| Change in Quality of Life Physical Health Composite Scores Using Short Form Health Survey (SF-36) | Change was calculated as the value at 12 months minus the value at baseline. The 36-Item Short Form Health Survey (SF-36) is used to determine a physical composite score based on following subscales: limitations in physical activities because of health problems; limitations in usual role activities because of physical health problems; bodily pain; vitality (energy and fatigue); and general health perceptions. The subscale scores are transformed into a range from 0 to 100, with 0=worst HRQL, 100=best HRQL. The physical component scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score, with higher scores indicating better health status. | 12 Months | 
| Quality of Life-Change in SF-36 Mental Health Composite Score Using Short Form Survey (SF-36) | Change was calculated as the value at 12 months minus the value at baseline. The 36-Item Short Form Health Survey (SF-36) is used to determine a mental composite score based on the following subscales: general mental health (psychological distress and well-being); limitations in usual role activities because of emotional problems; and general health perceptions. The subscale scores are transformed into a range from 0 to 100, with 0=worst HRQL, 100=best HRQL. The physical and mental component scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score, with higher scores indicating better health status. | 12 months | 
| Change in 6-Minute Walk Score | 6 minute walk score was measured by change from baseline compared to 12-months post-procedure between the EPi-Sense and Catheter Ablation groups. | 12 months | 
| Change in Left Atrial Diameter | Change in Left Atrial Diameter at 6 months from baseline. | 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, Convergent Procedure, Combined Epicardial/ Endocardial Ablation, Hybrid Procedure, Radiofrequency Ablation, Arrhythmia, RF Ablation