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ABLATE Post Approval Study - Synergy Ablation Lesions for Non-Paroxysmal Atrial Fibrillation

NCT01694563 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 365

Last updated 2019-10-09

Study results available
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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.

Conditions

  • Persistent Atrial Fibrillation
  • Longstanding Persistent Atrial Fibrillation

Interventions

DEVICE

Synergy Ablation System

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.

Sponsors & Collaborators

  • AtriCure, Inc.

    lead INDUSTRY

Principal Investigators

  • Patrick McCarthy, MD · Chief, Division of Cardiac Surgery, Northwestern University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2017-10-23
Completion
2018-03-21

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01694563 on ClinicalTrials.gov