CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 24 enrolled
Drug / intervention
Hybrid: AtriCure Bipolar System & EP ablation proceduredevice
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/NCT01246466
NCT01246466N/ACompleted

Feasibility Trial of a Hybrid Approach for Treatment of Patients With Persistent or Longstanding Persistent Atrial Fibrillation With Radiofrequency Ablation

AtriCure, Inc.·interventional·Posted Nov 23, 2010·Updated Apr 1, 2021

In Brief

A clinical study evaluating Hybrid: AtriCure Bipolar System & EP ablation procedure for Persistent Atrial Fibrillation and Longstanding Persistent Atrial Fibrillation. Completed, enrolled 24 participants across 5 sites.

Detailed Summary

The purpose of this clinical investigation is to evaluate how safe a less invasive cardiac surgery is using the AtriCure Bipolar System combined with a catheter ablation procedure in treating AF, and how effective this combined procedure is using the AtriCure System in treating AF. The AtriCure Bipolar System will be used to perform the less invasive cardiac surgery and a standard electrophysiology catheter, currently available, will be used to perform the catheter ablation procedure. This surgical procedure is considered less invasive because it is done through tiny surgical punctures on the sides of the chest near the ribs instead of one large surgical incision of the breast bone to completely open the chest and access the heart, and it also avoids the need for the heart-lung bypass machine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 23, 2010
Enrollment StartDec 1, 2010
Primary CompletionDec 1, 2012
Study CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 15.6 years ago

Interventions

Hybrid: AtriCure Bipolar System & EP ablation proceduredevice

AtriCure Bipolar System plus a catheter ablation