Efficacy Study for Surgery After Previous Failed Catheter Ablation

Atrial Fibrillation Ablation Clinical Trial

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Official title:

Surgery After Previous Failed Catheter Ablation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01034852
• Other study ID #: 09.018
• Status: Completed
• Phase: N/A
• First received: December 17, 2009
• Last updated: February 17, 2012
• Start date: May 2009
• Est. completion date: January 2011

Study information

• Verified date: February 2012
• Source: Cardiopulmonary Research Science and Technology Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation Ablation

Intervention

Procedure:
• Totally Thoracoscopic Maze
Epicardial pulmonary vein isolation with additional lesions as determined to be necessary by physician

Locations

Country	Name	City	State
United States	Cardiopulmonary Research Science and Technology Institute	Dallas	Texas
United States	Endovascular Research	Springfield	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
Cardiopulmonary Research Science and Technology Institute	AtriCure, Inc., Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Record and evaluate all complications associated with the surgical procedure.		1 year post operatively	Yes
Secondary	Evaluate usage of anticoagulants at 6 and 12 months.		1 year post operatively	No
Secondary	Determine the % of Pulmonary Veins that were electrically isolated by intra-operative, pre-surgical mapping.		1 year post operatively	No

External Links

•   non-profit research organization, trial sponsor