Back to resultsGENESIS Feasibility Study of the BARD Over-the-Wire Mesh Ablation System for the Treatment of Paroxysmal Atrial Fibrillation (GENESIS)
Primary Purpose
Paroxysmal Atrial Fibrillation
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Catheter Ablation of Paroxysmal Atrial Fibrillation
Sponsored by
About this trial
This is an interventional treatment trial for Paroxysmal Atrial Fibrillation focused on measuring Paroxysmal Atrial Fibrillation, Catheter Ablation, Pulmonary Vein Isolation, Radio Frequency Ablation
Eligibility 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.
Sites / Locations
- University Hospital
- Southlake Regional Health Centre
- Herz-und Gefässzentrum Bad Bevensen
- Deutsches Herzzentrum Berlin (DHZB)
- Herzzentrum Mūnchen
- The Heart Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Over-the-Wire Mesh Ablation System
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01430949
Brief Title
GENESIS Feasibility Study of the BARD Over-the-Wire Mesh Ablation System for the Treatment of Paroxysmal Atrial Fibrillation
Acronym
GENESIS
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
C. R. Bard
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation
Keywords
Paroxysmal Atrial Fibrillation, Catheter Ablation, Pulmonary Vein Isolation, Radio Frequency Ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Over-the-Wire Mesh Ablation System
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Catheter Ablation of Paroxysmal Atrial Fibrillation
Other Intervention Name(s)
GENESIS, BEP-4409, Bard Over-the-Wire Mesh Ablation System, OTW MAS, Paroxysmal Atrial Fibrillation, PAF, Feasibility
Intervention Description
Catheter ablation for the treatment of paroxysmal atrial fibrillation. A pulmonary vein isolation procedure will be performed using the OTW MAS and radiofrequency ablation.
Primary Outcome Measure Information:
Title
Efficacy
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Safety
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Ciavarella, MD
Organizational Affiliation
CR Bard Inc
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Southlake Regional Health Centre
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y8C3
Country
Canada
Facility Name
Herz-und Gefässzentrum Bad Bevensen
City
Bad Bevensen
ZIP/Postal Code
29549
Country
Germany
Facility Name
Deutsches Herzzentrum Berlin (DHZB)
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Herzzentrum Mūnchen
City
Munich
ZIP/Postal Code
80636
Country
Germany
Facility Name
The Heart Hospital
City
London
ZIP/Postal Code
W1G 8HP
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
GENESIS Feasibility Study of the BARD Over-the-Wire Mesh Ablation System for the Treatment of Paroxysmal Atrial Fibrillation
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