Efficacy Study for Surgery After Previous Failed Catheter Ablation

NCT ID: NCT01034852

Last Updated: 2012-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2011-01-31

Brief Summary

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Specific Aims: The primary objective of this registry is to determine the percentage of patients who are free from atrial fibrillation (AF) at 6 and 12 months following a surgical ablation procedure when the patient has a history of failing one or more previous catheter based ablations for AF. The first 3 months following surgical ablation will be a blanking period; any arrhythmia occurring during this time will not be used to determine success.

Primary Objectives:

1. Determine the percent success of surgical ablation for AF at 6, and 12 months both on and off of antiarrhythmic drugs (AAD) following a failed catheter based ablation for AF
2. Record and evaluate all complications associated with the surgical procedure.

Secondary Objectives:

1. Evaluate usage of anticoagulants at 6, and 12 months.
2. Determine the percentage of Pulmonary Veins (PV) that were electrically isolated by intra-operative, pre-surgical mapping

Detailed Description

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Conditions

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Atrial Fibrillation Ablation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Surgical ablation

Patients undergoing surgical ablation for Atrial Fibrillation that have failed one or more previous attempts at catheter ablation for Atrial Fibrillation

Totally Thoracoscopic Maze

Intervention Type PROCEDURE

Epicardial pulmonary vein isolation with additional lesions as determined to be necessary by physician

Interventions

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Totally Thoracoscopic Maze

Epicardial pulmonary vein isolation with additional lesions as determined to be necessary by physician

Intervention Type PROCEDURE

Other Intervention Names

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Minimally invasive maze Cox Maze procedure

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of atrial fibrillation
* Has undergone one or more catheter based ablation procedures for AF and the procedure failed
* Has undergone a minimal access surgical ablation procedure for the treatment of AF following failure of catheter based ablation for AF
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AtriCure, Inc.

INDUSTRY

Sponsor Role collaborator

Virginia Commonwealth University

OTHER

Sponsor Role collaborator

Cardiopulmonary Research Science and Technology Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James R Edgerton, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiopulmonary Research Science and Technology Institute

Locations

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Endovascular Research

Springfield, Oregon, United States

Site Status

Cardiopulmonary Research Science and Technology Institute

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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09.018

Identifier Type: -

Identifier Source: org_study_id

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