Efficacy Study for Surgery After Previous Failed Catheter Ablation

Completed

• Conditions: Atrial Fibrillation Ablation
• Interventions: Procedure: Totally Thoracoscopic Maze

• Registration Number: NCT01034852
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-12-17
• Study First Submitted QC: 2009-12-17
• Study First Posted: 2009-12-18
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-17
• Last Update Posted: 2012-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surgical ablation	Totally Thoracoscopic Maze	Patients undergoing surgical ablation for Atrial Fibrillation that have failed one or more previous attempts at catheter ablation for Atrial Fibrillation

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Endovascular Research; 🇺🇸 Springfield, Oregon, United States

Cardiopulmonary Research Science and Technology Institute; 🇺🇸 Dallas, Texas, United States