NCT01984346

CONVERGE - Epi/Endo Ablation For Treatment of Persistent Atrial Fibrillation(AF)

Convergence Of Epicardial And Endocardial Radiofrequency (RF) Ablation For The Treatment Of Symptomatic Persistent AF

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: AtriCure, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Persistent Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax	Convergent Epicardial Endocardial Ablation Procedure
DEVICE	Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering	Endocardial Catheter Ablation Procedure

Timeline

• Start date: 2013-12-01
• Primary completion: 2019-08-01
• Completion: 2023-10-01
• First posted: 2013-11-14
• Last updated: 2023-11-13
• Results posted: 2022-02-10

Locations

27 sites across 2 countries: United States, United Kingdom