CONVERGE - Epi/Endo Ablation For Treatment of Persistent Atrial Fibrillation(AF)
- Conditions
- Persistent Atrial Fibrillation
- Interventions
- Device: AtriCure EPi-Sense-AF Guided Coagulation System with VisiTraxDevice: Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering
- Registration Number
- NCT01984346
- Lead Sponsor
- AtriCure, Inc.
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 170
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Convergent Procedure Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment Convergent Procedure AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment Standalone Endocardial Catheter Ablation Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering Procedure/Surgery: Endocardial Catheter Ablation Treatment
- Primary Outcome Measures
Name Time Method Primary Efficacy Endpoint - Number of Participants to Achieve Freedom From AF/AT/AFL. 12 Months 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.
Primary Safety Analysis 30 days 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.
- Secondary Outcome Measures
Name Time Method Change in Quality of Life Physical Health Composite Scores Using Short Form Health Survey (SF-36) 12 Months 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.
Change in Atrial Fibrillation Severity Scale (AFSS) 12 months 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.
AF Freedom Through 12 Months- Absent of an Increased Dose or New Class I/III AAD's. 12 Months Number of patients with AF Freedom through 12 Months (ITT Population) absent of an increased dose or new class I/III AAD's
Number of Subjects With AF Burden Reduction of at Least 90% at 12 Months Relative to Baseline, Regardless of Class I/III AADs. 12 Months Number of subjects with AF freedom through 12 months achieved in the EPi-Sense group compared to subjects in the Catheter Ablation group.
Secondary Safety Endpoint - Serious Adverse Events Through 12 Months Post-procedure. 12 month 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.
Number of Patients With AF Burden Reduction of at Least 90% at 12 Months Compared to Baseline 12 Months 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.
Quality of Life-Change in SF-36 Mental Health Composite Score Using Short Form Survey (SF-36) 12 months 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.
Change in 6-Minute Walk Score 12 months 6 minute walk score was measured by change from baseline compared to 12-months post-procedure between the EPi-Sense and Catheter Ablation groups.
Change in Left Atrial Diameter 6 Months Change in Left Atrial Diameter at 6 months from baseline.
Trial Locations
- Locations (27)
East Carolina University - Vidant Medical Center
🇺🇸Greenville, North Carolina, United States
Genesys Regional Medical Center
🇺🇸Grand Blanc, Michigan, United States
Heart Center Research LLC
🇺🇸Huntsville, Alabama, United States
St. Vincent's HealthCare
🇺🇸Jacksonville, Florida, United States
Wake Medical Center / Cary Research Group
🇺🇸Raleigh, North Carolina, United States
Cardiology Associates Research, LLC
🇺🇸Tupelo, Mississippi, United States
Medstar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Staten Island University Hospital
🇺🇸Staten Island, New York, United States
Palm Beach Gardens Medical Center
🇺🇸Palm Beach Gardens, Florida, United States
UPMC Pinnacle Hospitals
🇺🇸Harrisburg, Pennsylvania, United States
St. Bartholomew's Hospital
🇬🇧London, United Kingdom
Guy's and St. Thomas Hospital
🇬🇧London, United Kingdom
Mt Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Cardiovascular Research Foundation of Louisiana
🇺🇸Baton Rouge, Louisiana, United States
Riverside Hospital / OhioHealth
🇺🇸Columbus, Ohio, United States
Maimonides Medical Center
🇺🇸Brooklyn, New York, United States
Emory University - St. Joseph's Hospital
🇺🇸Atlanta, Georgia, United States
St. Vincent Medical Group Inc.
🇺🇸Indianapolis, Indiana, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Allegheny-Singer Research Institute
🇺🇸Pittsburgh, Pennsylvania, United States
STAR Clinical Trials LLC
🇺🇸San Antonio, Texas, United States
Lahey Clinic
🇺🇸Burlington, Massachusetts, United States
Summa Health System
🇺🇸Akron, Ohio, United States
Grandview Medical Center
🇺🇸Birmingham, Alabama, United States
Rose Medical Center / Medical Center of Aurora
🇺🇸Denver, Colorado, United States
Virginia Cardiovascular Specialists
🇺🇸Richmond, Virginia, United States
Austin Heart PLLC
🇺🇸Austin, Texas, United States