Convergence Of Epicardial And Endocardial Radiofrequency (RF) Ablation For The Treatment Of Symptomatic Persistent AF
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Persistent Atrial Fibrillation
- Sponsor
- AtriCure, Inc.
- Enrollment
- 170
- Locations
- 27
- Primary Endpoint
- Primary Efficacy Endpoint - Number of Participants to Achieve Freedom From AF/AT/AFL.
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Primary Efficacy Endpoint - Number of Participants to Achieve Freedom From AF/AT/AFL.
Time Frame: 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
Time Frame: 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 Outcomes
- Change in Quality of Life Physical Health Composite Scores Using Short Form Health Survey (SF-36)(12 Months)
- AF Freedom Through 12 Months- Absent of an Increased Dose or New Class I/III AAD's.(12 Months)
- Change in Atrial Fibrillation Severity Scale (AFSS)(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.(12 Months)
- Secondary Safety Endpoint - Serious Adverse Events Through 12 Months Post-procedure.(12 month)
- Number of Patients With AF Burden Reduction of at Least 90% at 12 Months Compared to Baseline(12 Months)
- Quality of Life-Change in SF-36 Mental Health Composite Score Using Short Form Survey (SF-36)(12 months)
- Change in 6-Minute Walk Score(12 months)
- Change in Left Atrial Diameter(6 Months)