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Post-Market Randomized Trial: Endoscopically- Guided Ablation vs. Radiofrequency Ablation — En-GARDE  

Paroxysmal Atrial Fibrillation Clinical Trial

Official title:
Post-Market Randomized Controlled Trial: Endoscopically- Guided Ablation vs. Radiofrequency Ablation GuideD by Electroanatomical Mapping to Achieve Permanent Pulmonary Vein Isolation (En-GARDE)

Clinical Trial Summary

To compare the safety and chronic Pulmonary Vein isolation of 2 ablation types.

1. visually guided ablation (VGA) using the EAS-AC and

2. radiofrequency ablation

Clinical Trial Description

The goal of the study was to compare two interventions, visually-guided endoscopic ablation to standard-of-care radiofrequency (RF) ablation. The study was terminated early by the Sponsor for business reasons before any participants were randomized or treated with RF ablation. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01057394
Study type Interventional
Source CardioFocus
Contact
Status Terminated
Phase Phase 4
Start date December 2009
Completion date June 2011
View Details
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