Efficacy Study for Surgery After Previous Failed Catheter Ablation (SAVED)

February 17, 2012 updated by: Cardiopulmonary Research Science and Technology Institute

Surgery After Previous Failed Catheter Ablation

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Springfield, Oregon, United States, 97477
        • Endovascular Research
    • Texas
      • Dallas, Texas, United States, 75230
        • Cardiopulmonary Research Science and Technology Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients that have undergone surgical ablation after failing catheter based ablation at investigator sites

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Surgical ablation
Patients undergoing surgical ablation for Atrial Fibrillation that have failed one or more previous attempts at catheter ablation for Atrial Fibrillation
Procedure: Totally Thoracoscopic Maze
Epicardial pulmonary vein isolation with additional lesions as determined to be necessary by physician
Other Names:
  • Minimally invasive maze
  • Cox Maze procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine the efficacy of surgical ablation for AF at 6, & 12 months both on and off of antiarrhythmic drugs following a failed catheter based ablation for AF.
Time Frame: 1 year post operatively
1 year post operatively
Record and evaluate all complications associated with the surgical procedure.
Time Frame: 1 year post operatively
1 year post operatively

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate usage of anticoagulants at 6 and 12 months.
Time Frame: 1 year post operatively
1 year post operatively
Determine the % of Pulmonary Veins that were electrically isolated by intra-operative, pre-surgical mapping.
Time Frame: 1 year post operatively
1 year post operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardiopulmonary Research Science and Technology Institute

Collaborators

Virginia Commonwealth University
AtriCure, Inc.

Investigators

  • Principal Investigator: James R Edgerton, MD, Cardiopulmonary Research Science and Technology Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

December 17, 2009

First Submitted That Met QC Criteria

December 17, 2009

First Posted (Estimate)

December 18, 2009

Study Record Updates

Last Update Posted (Estimate)

February 22, 2012

Last Update Submitted That Met QC Criteria

February 17, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09.018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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