Clinical Trials Directory

Trials / Completed

CompletedNCT01034852

Efficacy Study for Surgery After Previous Failed Catheter Ablation

Surgery After Previous Failed Catheter Ablation

Status
Completed
Phase
Study type
Observational
Enrollment
45 (actual)
Sponsor
Cardiopulmonary Research Science and Technology Institute · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
PROCEDURETotally Thoracoscopic MazeEpicardial pulmonary vein isolation with additional lesions as determined to be necessary by physician

Timeline

Start date
2009-05-01
Primary completion
2011-01-01
Completion
2011-01-01
First posted
2009-12-18
Last updated
2012-02-22

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01034852. Inclusion in this directory is not an endorsement.

Efficacy Study for Surgery After Previous Failed Catheter Ablation (NCT01034852) · Clinical Trials Directory