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

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

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.

Study Overview

• Status: Completed
• Conditions: Paroxysmal Atrial Fibrillation
• Intervention / Treatment: Procedure: Catheter Ablation of Paroxysmal Atrial Fibrillation

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).

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • University Hospital
    • Newmarket, Ontario, Canada, L3Y8C3
      • Southlake Regional Health Centre
• Germany
  • Bad Bevensen, Germany, 29549
    • Herz-Und Gefasszentrum Bad Bevensen
  • Berlin, Germany, 13353
    • Deutsches Herzzentrum Berlin (DHZB)
  • Munich, Germany, 80636
    • Herzzentrum München
• United Kingdom
  • London, United Kingdom, W1G 8HP
    • The Heart Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Symptomatic PAF refractory to at least one Class I-IV antiarrhythmic drug.
• Minimum one documented PAF episode >30 sec duration within prior 12 months.
• Minimum three PAF episodes during prior 12 months.
• 18 years or older.

Exclusion Criteria:

• AF due to reversible causes.
• More than 2 cardioversions during the 6 months
• Previous surgical or catheter based ablation of the LA to treat AF.
• Permanent or persistent AF.
• Requirement for ablation lesions other than those defined in protocol
• LA > 50 mm in major dimension(measured by TTE).
• Any single PV > 25 mm in major diameter and/or presence of common os not suitable for ablation
• Ejection fraction <35%.
• Patent foramen ovale (PFO)or atrial septal defect (ASD)
• Cardiac myopathy (e.g., HOCM, cardiac sarcoidosis).
• Myocardial infarction in previous 2 months screening.
• Currently unstable angina.
• Any cardiac surgery in previous 3 months prior to screening.
• Implantable device capable of recording cardiac rhythm, (e.g ICD, pacemaker or implantable loop recorder.
• Clinically significant valvular heart disease or a replacement heart valve.
• Congestive heart failure (NYHA classification III or IV).
• Renal dialysis or creatinine > 2.0 mg/dl.
• Contraindication to anti-coagulation therapy (e.g., warfarin, heparin).
• Contraindication to transseptal procedure.
• Any cerebral ischemic event, including TIA in the 6 months prior to screening.
• Any known uncontrolled bleeding or thrombotic disorder.
• Women who are known to be pregnant or nursing.
• Uncontrolled hyperthyroidism.
• Patients currently enrolled in any other study during the 30 days prior to screening.
• Any other significant uncontrolled or unstable medical condition (e.g., active systemic infection).
• A life expectancy of less than one year.
• Currently documented intracardiac thrombus.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.; Other Names: GENESIS; BEP-4409; Bard Over-the-Wire Mesh Ablation System; OTW MAS; Paroxysmal Atrial Fibrillation; PAF; Feasibility

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	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.	12 months

Collaborators and Investigators

• Sponsor: C. R. Bard
• Investigators: Study Chair: David Ciavarella, MD, CR Bard Inc

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: September 7, 2011
• First Submitted That Met QC Criteria: September 8, 2011
• First Posted (Estimate): September 9, 2011

Study Record Updates

• Last Update Posted (Estimate): September 30, 2013
• Last Update Submitted That Met QC Criteria: September 27, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Catheter Ablation; Paroxysmal Atrial Fibrillation; Pulmonary Vein Isolation; Radio Frequency Ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: BEP-4409-2010