Evaluating Treatment Management of Atrial Fibrillation with the BWI IRE Ablation System
Recruiting
18 years - 75 years
All
20 participants needed
1 Location
Brief description of study
The purpose of this study is to provide information about the safety and long-term effectiveness of the BWI irreversible electroporation (IRE) ablation system consisting of the TRUPULSE™ Generator and VARIPULSE™ Catheter. The Biosense Webster Inc. (BWI) IRE Ablation system is being studied for use in the treatment of Paroxysmal Atrial Fibrillation (PAF) in subjects who have failed at least one antiarrhythmic drug (medication to treat symptoms of PAF). The BWI IRE Ablation system is an investigational device that has not been approved by the FDA for the treatment of PAF.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Medical Research,
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Age: 18 years - 75 years
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Gender: All
Have Paroxysmal Atrial Fibrillation (PAF), which is causing your palpitations, chronic fatigue, weakness, shortness of breath, or pain. Age 18 to 75
Updated on
04 Aug 2024.
Study ID: 851240