A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Catheter System
Sponsored by Biosense Webster, Inc.
About this study
The purpose of this study is to evaluate the long-term safety and effectiveness of the FDA approved VARIPULSE catheter system for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF).
Where this study is enrolling (3)
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Phoenix Cardiovascular Research Group
Phoenix, Arizona
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Tucson Medical Center Pima Heart and Vascular
Tucson, Arizona
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- I'm interested
Edward Hospital Midwest Cardiovascular Institute
Naperville, Illinois
Who can participate
Inclusion criteria
- ✓Symptomatic paroxysmal Atrial Fibrillation (AF) who, in the opinion of the investigator, are candidates for catheter ablation for AF
- ✓Refractory (that is, ineffective, not tolerated, or not desired) or contraindicated to at least one Class I/III antiarrhythmic drugs (AAD)
- ✓Willing and capable of providing consent
- ✓Able and willing to comply with all pre-, post-, and follow-up testing and requirements
Exclusion criteria
- ✕Previously diagnosed with persistent or long-standing persistent AF (more than \[\>\] 7 days in duration)
- ✕Previous surgical or catheter ablation for AF
- ✕Significant congenital anomaly or medical problem that in the opinion of the investigator would be a contraindication to catheter ablation for AF
- ✕Current enrollment in an investigational study evaluating another device or drug
- ✕Life expectancy less than 12 months
- ✕Any contraindications as defined in the Protocol
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Trial data sourced from ClinicalTrials.gov.