Status:
COMPLETED
GENESIS Feasibility Study of the BARD Over-the-Wire Mesh Ablation System for the Treatment of Paroxysmal Atrial Fibrillation
Lead Sponsor:
C. R. Bard
Conditions:
Paroxysmal Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ra...
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 abo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01430949
Start Date
November 1 2011
End Date
August 1 2013
Last Update
September 30 2013
Active Locations (6)
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1
University Hospital
London, Ontario, Canada, N6A 5A5
2
Southlake Regional Health Centre
Newmarket, Ontario, Canada, L3Y8C3
3
Herz-und Gefässzentrum Bad Bevensen
Bad Bevensen, Germany, 29549
4
Deutsches Herzzentrum Berlin (DHZB)
Berlin, Germany, 13353