NCT01622907

Hybrid Staged Operating Room and Interventional Catheter Ablation for Atrial Fibrillation

European Multicenter Study Using Hybrid Staged Operating Room and Interventional Catheter Ablation Techniques to Treat Chronic AF

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Prospective, multi-center, investigator-driven trial. This study hypothesizes that combining surgical endoscopic and transcatheter techniques in a staged fashion provides superior clinical outcomes than isolated surgical/EP approaches in patients with persistent AF lasting \> 1 year but \> 5 years. The proposed procedure involves the creation of cardiac lesions with epicardially applied radiofrequency (RF) ablation through a minimally invasive surgical (MIS) approach followed by a delayed EP ablation procedure performed at 1-2 months from the surgical operation.

Detailed description

New ablative technologies have been developed to simplify the original "cut and sew" Cox Maze procedure so that it can now be used for routine treatment of AF in patients undergoing open-heart surgery, as well as in a stand-alone arrhythmia procedure. A minimally invasive, thoracoscopic surgical treatment of AF is able to address both the triggers for AF by pulmonary vein isolation and the left posterior atrial wall exclusion, which after the pulmonary veins is the next most important atrial substrate in the promotion of AF. New hybrid procedures attempt to combine the success rate and the minimally invasive nature of thoracoscopic mini-Maze with the effectiveness and short recovery times associated with catheter ablation. The key is blocking signals that cause the arrhythmia from both outside (epicardial) and inside (endocardial) the heart. Suboptimal results of both catheter ablation and surgery suggest that success in the treatment of long standing persistent AF and persistent lone AF will benefit from a close collaboration between the cardiothoracic surgeon and the electrophysiologist, to offer patients the best available combination of treatments for any given set of cardiovascular lesions. Hybrid treatment for AF is being increasingly adopted in Europe and the United States and has been assessed for the treatment of AF at the Coordinating Center (Brescia, Italy) with promising results.

Conditions

• Atrial Fibrillation

Timeline

• Start date: 2012-05-01
• Primary completion: 2013-04-01
• Completion: 2015-04-01
• First posted: 2012-06-19
• Last updated: 2012-06-19

Locations

10 sites across 5 countries: France, Germany, Italy, Poland, United Kingdom