NCT01034852

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. 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. 2.Record and evaluate all complications associated with the surgical procedure.
  3. 3.Evaluate usage of anticoagulants at 6, and 12 months.
  4. 4.Determine the percentage of Pulmonary Veins (PV) that were electrically isolated by intra-operative, pre-surgical mapping

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2009

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

February 22, 2012

Status Verified

February 1, 2012

Enrollment Period

1.7 years

First QC Date

December 17, 2009

Last Update Submit

February 17, 2012

Conditions

Atrial Fibrillation Ablation

Keywords

Atrial FibrillationMazeAblation

Outcome Measures

Primary Outcomes (2)

  • 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.

    1 year post operatively

  • Record and evaluate all complications associated with the surgical procedure.

    1 year post operatively

Secondary Outcomes (2)

  • Evaluate usage of anticoagulants at 6 and 12 months.

    1 year post operatively

  • Determine the % of Pulmonary Veins that were electrically isolated by intra-operative, pre-surgical mapping.

    1 year post operatively

Study Arms (1)

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

Interventions

Totally Thoracoscopic MazePROCEDURE

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

Also known as: Minimally invasive maze, Cox Maze procedure
Surgical ablation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Endovascular Research

Springfield, Oregon, 97477, United States

Location

Cardiopulmonary Research Science and Technology Institute

Dallas, Texas, 75230, United States

Location

Biospecimen

Retention: NONE RETAINED

no biospecimens will be obtained.

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Maze Procedure

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ablation TechniquesSurgical Procedures, OperativeCardiac Surgical ProceduresCardiovascular Surgical ProceduresThoracic Surgical Procedures

Study Officials

  • James R Edgerton, MD

    Cardiopulmonary Research Science and Technology Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2009

First Posted

December 18, 2009

Study Start

May 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

February 22, 2012

Record last verified: 2012-02

Locations

US(2)