CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Ablation procedure staged catheter ablationdevice
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/NCT01661205
NCT01661205N/ACompleted
CompareCT.gov

Feasibility Trial of a Staged Epicardial & Endocardial Approach for Treatment of Patients With Persistent or Long Standing Persistent Atrial Fibrillation With Radiofrequency Ablation

AtriCure, Inc.·interventional·Posted Aug 9, 2012·Updated May 17, 2017

In Brief

A clinical study evaluating Ablation procedure staged catheter ablation for Atrial Fibrillation. Completed, enrolled 30 participants across 6 sites in 3 countries.

Detailed Summary

The purpose of this study is to assess the safety and technical feasibility of treating subjects with Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation in a minimally invasive thoracoscopic ablation procedure utilizing the AtriCure Bipolar System, with mapping and additional lesion creation/ gap closure (as needed) provided by currently approved catheter technology, when the epicardial and endocardial phases are performed in a staged manner within 1-10 days apart, during the same hospitalization.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation
CountriesBelgium, Netherlands, United States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 9, 2012
Enrollment StartAug 1, 2012
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 13.9 years ago

Interventions

Ablation procedure staged catheter ablationdevice

AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart