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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bard Electrophysiology
ClinicalTrials.gov Identifier:
NCT01430949
First received: September 7, 2011
Last updated: August 23, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Paroxysmal Atrial Fibrillation
 Procedure: Catheter Ablation of Paroxysmal Atrial Fibrillation
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bard Electrophysiology:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 60
Study Start Date: November 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01430949

Locations
Canada, Ontario
University Hospital
London, Ontario, Canada, N6A 5A5
Southlake Regional Health Centre
Newmarket, Ontario, Canada, L3Y8C3
Germany
Herz-und Gefässzentrum Bad Bevensen
Bad Bevensen, Germany, 29549
Deutsches Herzzentrum Berlin (DHZB)
Berlin, Germany, 13353
Herzzentrum Mūnchen
Munich, Germany, 80636
United Kingdom
The Heart Hospital
London, United Kingdom, W1G 8HP
Sponsors and Collaborators
Bard Electrophysiology
Investigators
Study Chair: David Ciavarella, MD CR Bard Inc
  More Information

No publications provided

Responsible Party: Bard Electrophysiology
ClinicalTrials.gov Identifier: NCT01430949     History of Changes
Other Study ID Numbers: BEP-4409-2010
Study First Received: September 7, 2011
Last Updated: August 23, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Canada: Health Canada
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bard Electrophysiology:
Paroxysmal Atrial Fibrillation
Catheter Ablation
Pulmonary Vein Isolation
Radio Frequency Ablation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013