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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
170
Convergent Epicardial Endocardial Ablation Procedure
Endocardial Catheter Ablation Procedure
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.
Time frame: 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.
Time frame: 30 days
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.
Time frame: 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.
Time frame: 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
Time frame: 12 Months
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Grandview Medical Center
Birmingham, Alabama, United States
Heart Center Research LLC
Huntsville, Alabama, United States
Rose Medical Center / Medical Center of Aurora
Denver, Colorado, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
St. Vincent's HealthCare
Jacksonville, Florida, United States
Mt Sinai Medical Center
Miami Beach, Florida, United States
Palm Beach Gardens Medical Center
Palm Beach Gardens, Florida, United States
Emory University - St. Joseph's Hospital
Atlanta, Georgia, United States
St. Vincent Medical Group Inc.
Indianapolis, Indiana, United States
Cardiovascular Research Foundation of Louisiana
Baton Rouge, Louisiana, United States
...and 17 more locations
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
Change in Left Atrial Diameter
Change in Left Atrial Diameter at 6 months from baseline.
Time frame: 6 Months