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

Cardiopulmonary Research Science and Technology Institute

Status: Completed

Conditions: Atrial Fibrillation Ablation

Treatments: Procedure: Totally Thoracoscopic Maze

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01034852

09.018

Details and patient eligibility

About

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

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

45 participants in 1 patient group

Surgical ablation

Description:

Patients undergoing surgical ablation for Atrial Fibrillation that have failed one or more previous attempts at catheter ablation for Atrial Fibrillation

Treatment:

Procedure: Totally Thoracoscopic Maze