CONVERGE - Epi/Endo Ablation For Treatment of Persistent Atrial Fibrillation(AF) (CONVERGE)
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|ClinicalTrials.gov Identifier: NCT01984346|
Recruitment Status : Active, not recruiting
First Posted : November 14, 2013
Last Update Posted : January 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Persistent Atrial Fibrillation||Device: Convergent Procedure EPi-Sense-AF Guided Coagulation System Device: Endocardial Catheter Ablation||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||153 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Convergence Of Epicardial And Endocardial Radiofrequency (RF) Ablation For The Treatment Of Symptomatic Persistent AF|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||August 2024|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01984346
|Principal Investigator:||David DeLurgio, MD||Emory St Joseph's Hospital|