CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 170 enrolled
Drug / intervention
AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01984346
NCT01984346N/ACompleted
CompareCT.gov

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

AtriCure, Inc.·interventional·Posted Nov 14, 2013·Updated Nov 13, 2023

In Brief

A clinical study evaluating AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax and Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering for Persistent Atrial Fibrillation. Completed, enrolled 170 participants across 27 sites in 2 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPersistent Atrial Fibrillation
CountriesUnited Kingdom, United States
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 14, 2013
Enrollment StartDec 1, 2013
Primary CompletionAug 1, 2019
Study CompletionOct 1, 2023
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 12.6 years ago

Interventions

AtriCure EPi-Sense-AF Guided Coagulation System with VisiTraxdevice

Convergent Epicardial Endocardial Ablation Procedure

Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steeringdevice

Endocardial Catheter Ablation Procedure