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Efficacy Study for Surgery After Previous Failed Catheter Ablation

NCT01034852 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 45

Last updated 2012-02-22

No results posted yet for this study

Summary

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

Conditions

  • Atrial Fibrillation Ablation

Interventions

PROCEDURE

Totally Thoracoscopic Maze

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

Sponsors & Collaborators

  • AtriCure, Inc.

    collaborator INDUSTRY

  • Virginia Commonwealth University

    collaborator OTHER

  • Cardiopulmonary Research Science and Technology Institute

    lead OTHER

Principal Investigators

  • James R Edgerton, MD · Cardiopulmonary Research Science and Technology Institute

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2011-01-31
Completion
2011-01-31

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 NCT01034852 on ClinicalTrials.gov