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

This study has been completed.
Sponsor:
Collaborators:
AtriCure, Inc.
Virginia Commonwealth University
Information provided by (Responsible Party):
Cardiopulmonary Research Science and Technology Institute
ClinicalTrials.gov Identifier:
NCT01034852
First received: December 17, 2009
Last updated: February 17, 2012
Last verified: February 2012
  Purpose

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 Intervention
Atrial Fibrillation Ablation
Procedure: Totally Thoracoscopic Maze

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Surgery After Previous Failed Catheter Ablation

Resource links provided by NLM:


Further study details as provided by Cardiopulmonary Research Science and Technology Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Record and evaluate all complications associated with the surgical procedure. [ Time Frame: 1 year post operatively ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluate usage of anticoagulants at 6 and 12 months. [ Time Frame: 1 year post operatively ] [ Designated as safety issue: No ]
  • Determine the % of Pulmonary Veins that were electrically isolated by intra-operative, pre-surgical mapping. [ Time Frame: 1 year post operatively ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

no biospecimens will be obtained.


Enrollment: 45
Study Start Date: May 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Cardiopulmonary Research Science and Technology Institute
ClinicalTrials.gov Identifier: NCT01034852     History of Changes
Other Study ID Numbers: 09.018
Study First Received: December 17, 2009
Last Updated: February 17, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 20, 2014