CONVERGE - Epi/Endo Ablation For Treatment of Persistent Atrial Fibrillation(AF) (CONVERGE)
|Persistent Atrial Fibrillation||Device: Convergent Procedure EPi-Sense-AF Guided Coagulation System Device: Endocardial Catheter Ablation|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Convergence Of Epicardial And Endocardial Radiofrequency (RF) Ablation For The Treatment Of Symptomatic Persistent AF|
- AF/AT/Atrial Flutter(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. [ Time Frame: 12 Months ]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 months post procedure follow-up visit.
|Study Start Date:||December 2013|
|Estimated Study Completion Date:||December 2022|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Experimental: Convergent Procedure
Convergent Procedure EPi-Sense-AF Guided Coagulation System
Device: Convergent Procedure EPi-Sense-AF Guided Coagulation System
Convergent Epicardial Endocardial Ablation Procedure
Other Name: EPi-Sense-AF Guided Coagulation System
Active Comparator: Standalone Endocardial Catheter Ablation
Endocardial Catheter Ablation Treatment
Device: Endocardial Catheter Ablation
Endocardial Catheter Ablation only
Other Name: Irrigated Endocardial Catheters
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01984346
|Contact: Tammy Davis, BSNemail@example.com|
|Contact: Shana Zink, BSfirstname.lastname@example.org|
Show 21 Study Locations
|Principal Investigator:||David DeLurgio, MD||Emory St Joseph's Hospital|