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

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ClinicalTrials.gov Identifier: NCT01034852
Recruitment Status : Completed
First Posted : December 18, 2009
Last Update Posted : February 22, 2012
Sponsor:
Collaborators:
AtriCure, Inc.
Virginia Commonwealth University
Information provided by (Responsible Party):
Cardiopulmonary Research Science and Technology Institute

Brief 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

Condition or disease Intervention/treatment
Atrial Fibrillation Ablation Procedure: Totally Thoracoscopic Maze

Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Surgery After Previous Failed Catheter Ablation
Study Start Date : May 2009
Primary Completion Date : January 2011
Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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 ]
  2. Record and evaluate all complications associated with the surgical procedure. [ Time Frame: 1 year post operatively ]

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

Biospecimen Retention:   None Retained
no biospecimens will be obtained.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients that have undergone surgical ablation after failing catheter based ablation at investigator sites
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01034852


Locations
United States, Oregon
Endovascular Research
Springfield, Oregon, United States, 97477
United States, Texas
Cardiopulmonary Research Science and Technology Institute
Dallas, Texas, United States, 75230
Sponsors and Collaborators
Cardiopulmonary Research Science and Technology Institute
AtriCure, Inc.
Virginia Commonwealth University
Investigators
Principal Investigator: James R Edgerton, MD Cardiopulmonary Research Science and Technology Institute

Additional Information:
Responsible Party: Cardiopulmonary Research Science and Technology Institute
ClinicalTrials.gov Identifier: NCT01034852     History of Changes
Other Study ID Numbers: 09.018
First Posted: December 18, 2009    Key Record Dates
Last Update Posted: February 22, 2012
Last Verified: February 2012

Keywords provided by Cardiopulmonary Research Science and Technology Institute:
Atrial Fibrillation
Maze
Ablation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes