NCT01430949

GENESIS Feasibility Study of the BARD Over-the-Wire Mesh Ablation System for the Treatment of Paroxysmal Atrial Fibrillation

A Single-Arm Multi-Center Trial of Radiofrequency Ablation for the Treatment of Paroxysmal Atrial Fibrillation Using the Bard Over-the-Wire Ablation System

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: C. R. Bard · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The Genesis Feasibility Study will collect clinical information on the use of the Bard Over-the-Wire Mesh Ablation System to access and perform electrophysiological mapping, cardiac stimulation and radiofrequency ablation in the region of the pulmonary vein (PV) ostia for the treatment of patients with Paroxysmal Atrial Fibrillation. Patients will be followed up for 12 months to assess the primary safety endpoint of Major Complications (a composite safety endpoint)and effectiveness, defined as Long-Term Success (freedom from recurrent atrial arrhythmia.

Detailed description

Atrial fibrillation (AF) is the most common sustained arrhythmia seen by the physician. Its prevalence in the population increases with age, and it is estimated to affect over 4% of the population above the age of 60. Common approaches to AF management includes the use of anti-arrhythmic drugs to control the arrhythmia. An alternative to treatment of AF using drug therapy is ablation of cardiac tissue, with the goal of disrupting the aberrant electrical pathways that cause AF through the creation of ablation lesions within the left atrium. There are several different approaches to creating lesions to treat AF, although both substrate derived and focal AF mechanisms share a common ablation therapy protocol in which the PVs are isolated by a series of ablation lines placed endocardially, either around the PV ostia or more proximally from the PV ostia at the atrial carinae. The Over-the-Wire Mesh Ablation System (OTW MAS) catheter is a combined mapping and ablation catheter designed to create lesions at the PV ostium. The Genesis Feasibility Study is designed to collect clinical information on the use of the OTW MAS to access and perform electrophysiological mapping, cardiac stimulation and radiofrequency ablation in the region of the pulmonary vein (PV) ostia for the treatment of patients with Paroxysmal Atrial Fibrillation (PAF).

Conditions

• Paroxysmal Atrial Fibrillation

Interventions

Type	Name	Description
PROCEDURE	Catheter Ablation of Paroxysmal Atrial Fibrillation	Catheter ablation for the treatment of paroxysmal atrial fibrillation. A pulmonary vein isolation procedure will be performed using the OTW MAS and radiofrequency ablation.

Timeline

• Start date: 2011-11-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2011-09-09
• Last updated: 2013-09-30

Locations

6 sites across 3 countries: Canada, Germany, United Kingdom