NCT01683045

Efficacy and Safety Study of the Estech COBRA® Surgical System to Treat Patients With a History of Irregular Heart Beats

Ablation for the Treatment of Concomitant Atrial Fibrillation in Non-Paroxysmal Patients (ATTAC-AF)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Endoscopic Technologies, Inc · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate that the Estech COBRA Surgical System is an effective treatment for patients with irregular heart beats who are undergoing heart surgery.

Detailed description

The objective of the trial is to demonstrate that the creation of epicardial and endocardial lesions with temperature-controlled radiofrequency (TCRF) ablation applied using the Estech COBRA® Surgical System during concomitant heart surgery is a safe and effective treatment for non-paroxysmal atrial fibrillation (AF).

Conditions

• Persistent Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	The Estech COBRA® Surgical System	The Estech COBRA® Surgical System has been designed to create epicardial and endocardial lesions on the heart using temperature controlled radiofrequency (TCRF) ablation with the Estech COBRA surgical probes. Temperature control provides a meaningful endpoint, maintaining tissue at safe yet effective temperatures to produce the desired lesion set. Internal probe cooling and advanced suction helps to ensure reproducible transmural (full-thickness) endocardial or epicardial lesions.

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-01-01
• Completion: 2014-05-01
• First posted: 2012-09-11
• Last updated: 2014-04-23

Locations

13 sites across 1 country: United States