Paroxysmal Atrial FibrillationPhase 2GENESISNCT01430949
GENESIS Feasibility Study of the BARD Over-the-Wire Mesh Ablation System for the Treatment of Paroxysmal Atrial Fibrillation
A Phase 2 study testing Catheter Ablation of Paroxysmal Atrial Fibrillation in people with Paroxysmal Atrial Fibrillation, run by C. R. Bard at 6 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- Catheter Ablation of Paroxysmal Atrial Fibrillation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Nov 2011to Aug 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 27Show fewer
- 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.
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Germany3 sites
Herz-und Gefässzentrum Bad Bevensen
Bad Bevensen, 29549
Deutsches Herzzentrum Berlin (DHZB)
Berlin, 13353
Herzzentrum Mūnchen
Munich, 80636
Canada2 sites
University Hospital
London, Ontario, N6A 5A5
Southlake Regional Health Centre
Newmarket, Ontario, L3Y8C3
About this study
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
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.
Read the 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
- Being tested
- Catheter Ablation of Paroxysmal Atrial Fibrillation
- Keywords
- Paroxysmal Atrial Fibrillation, Catheter Ablation, Pulmonary Vein Isolation, Radio Frequency Ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter Ablation of Paroxysmal Atrial FibrillationProcedure or surgery
Also called GENESIS, BEP-4409, Bard Over-the-Wire Mesh Ablation System, OTW MAS
Catheter ablation for the treatment of paroxysmal atrial fibrillation. A pulmonary vein isolation procedure will be performed using the OTW MAS and radiofrequency ablation.
| Study group | Role | What they receive |
|---|---|---|
| Over-the-Wire Mesh Ablation System | Experimental | Not described Receives: Procedure: Catheter Ablation of Paroxysmal Atrial Fibrillation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2011 (estimated)
- Study startNov 2011
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by C. R. BardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Ciavarella, MD, Study chair, CR Bard Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01430949
- Sponsor's protocol ID
- BEP-4409-2010
- Acronym
- GENESIS
- Status last verified
- Sep 2013
- First submitted
- 7 Sep 2011
- Last updated
- 30 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01430949
- Acronym / sponsor ID
- GENESIS / BEP-4409-2010
- Conditions
- Paroxysmal Atrial Fibrillation
- Keywords
- Paroxysmal Atrial Fibrillation, Catheter Ablation, Pulmonary Vein Isolation, Radio Frequency Ablation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 9 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Over-the-Wire Mesh Ablation System | Experimental | Procedure: Catheter Ablation of Paroxysmal Atrial Fibrillation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Catheter Ablation of Paroxysmal Atrial FibrillationAlso: GENESIS, BEP-4409, Bard Over-the-Wire Mesh Ablation System, OTW MASCatheter ablation for the treatment of paroxysmal atrial fibrillation. A pulmonary vein isolation procedure will be performed using the OTW MAS and radiofrequency ablation. | Procedure or surgery | Over-the-Wire Mesh Ablation System |
Primary outcome
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.
1 secondary outcome
Safety
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Ciavarella, MD study chair
CR Bard Inc
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Catheter Ablation of Paroxysmal Atrial Fibrillation in people with Paroxysmal Atrial Fibrillation, run by C. R. Bard at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Canada, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2013.