NCT01246466

Dual Epicardial Endocardial Persistent Atrial Fibrillation (AF) Study

Feasibility Trial of a Hybrid Approach for Treatment of Patients With Persistent or Longstanding Persistent Atrial Fibrillation With Radiofrequency Ablation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: AtriCure, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical investigation is to evaluate how safe a less invasive cardiac surgery is using the AtriCure Bipolar System combined with a catheter ablation procedure in treating AF, and how effective this combined procedure is using the AtriCure System in treating AF. The AtriCure Bipolar System will be used to perform the less invasive cardiac surgery and a standard electrophysiology catheter, currently available, will be used to perform the catheter ablation procedure. This surgical procedure is considered less invasive because it is done through tiny surgical punctures on the sides of the chest near the ribs instead of one large surgical incision of the breast bone to completely open the chest and access the heart, and it also avoids the need for the heart-lung bypass machine.

Conditions

• Persistent Atrial Fibrillation
• Longstanding Persistent Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Hybrid: AtriCure Bipolar System & EP ablation procedure	AtriCure Bipolar System plus a catheter ablation

Timeline

• Start date: 2010-12-01
• Primary completion: 2012-12-01
• Completion: 2013-11-01
• First posted: 2010-11-23
• Last updated: 2021-04-01
• Results posted: 2021-04-01

Locations

5 sites across 1 country: United States