CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 365 enrolled
Drug / intervention
Synergy Ablation Systemdevice
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/NCT01694563
NCT01694563N/ACompleted
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AtriCure Synergy Ablation Lesions for Non-Paroxysmal Forms of Atrial Fibrillation Treatment During Concomitant On-Pump Endo/Epicardial Cardiac Surgery

AtriCure, Inc.·interventional·Posted Sep 27, 2012·Updated Oct 9, 2019

In Brief

A clinical study evaluating Synergy Ablation System for Persistent Atrial Fibrillation and Longstanding Persistent Atrial Fibrillation. Completed, enrolled 365 participants across 49 sites.

Detailed Summary

The primary objective of this post-approval study is to evaluate the clinical outcomes in a cohort of patients with non-paroxysmal forms of atrial fibrillation (persistent or long-standing persistent) treated during commercial use of the AtriCure Synergy Ablation System by physicians performed the Maze IV procedure.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPersistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 27, 2012
Enrollment StartSep 1, 2012
Primary CompletionOct 23, 2017
Study CompletionMar 21, 2018
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 13.8 years ago

Interventions

Synergy Ablation Systemdevice

Patient will undergo an elective open cardiac surgical procedure to be performed on cardiopulmonary bypass for one or more of the following: * Coronary Artery Bypass Grafting (CABG) * Mitral valve repair or replacement * Aortic valve repair or replacement * Tricuspid valve repair or replacement The aim of the treatment is a complete bi-atrial Maze IV procedure which includes pulmonary vein isolation coupled with lesions made on both the left and right atria.