GENESIS Feasibility Study of the BARD Over-the-Wire Mesh Ablation System for the Treatment of Paroxysmal Atrial Fibrillation (GENESIS)
|Paroxysmal Atrial Fibrillation||Procedure: Catheter Ablation of Paroxysmal Atrial Fibrillation||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Single-Arm Multi-Center Trial of Radiofrequency Ablation for the Treatment of Paroxysmal Atrial Fibrillation Using the Bard Over-the-Wire Ablation System|
- Efficacy [ Time Frame: 12 months ]Freedom from recurrence of symptomatic atrial fibrillation, atrial tachycardia or atrial flutter. Includes both acute success (successful electrical isolation of all pulmonary veins) and chronic success. Re-treatment for AF with ablation during the 3 month blanking period will not constitute a treatment failure.
- Safety [ Time Frame: 12 months ]Incidence of device-related early-onset primary serious adverse events or adverse device effects. Includes serious adverse events occurring within 7 days of the index procedure and diagnosed at any time during the follow-up period.
|Study Start Date:||November 2011|
|Study Completion Date:||August 2013|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
|Experimental: Over-the-Wire Mesh Ablation System||
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.
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01430949
|London, Ontario, Canada, N6A 5A5|
|Southlake Regional Health Centre|
|Newmarket, Ontario, Canada, L3Y8C3|
|Herz-und Gefässzentrum Bad Bevensen|
|Bad Bevensen, Germany, 29549|
|Deutsches Herzzentrum Berlin (DHZB)|
|Berlin, Germany, 13353|
|Munich, Germany, 80636|
|The Heart Hospital|
|London, United Kingdom, W1G 8HP|
|Study Chair:||David Ciavarella, MD||CR Bard Inc|