This study will examine a new ablation catheter for the treatment of drug resistant paroxysmal atrial fibrillation. Atrial fibrillation is an irregular heart beat that causes the upper chambers of the heart to beat out of sync. Paroxysmal means this irregular heart beat starts and stops on its own. When medications used to keep your heart in rhythm no longer work or cause unwanted side effects an ablation procedure is recommended. For this study the FARAPULSE™ Pulsed Field Ablation System including the FARAWAVE™ Pulsed Field Ablation Catheter will be used. This system including the catheter are investigational meaning it has not been approved for use by the US Food and Drug Administration. (FDA) Participation in this study will last about a year and will include up to five in person visits and four remote/telephone visits.
This study is collecting data on patients who are having an ablation procedure to correct an irregular heart beat called an arrhythmia. During this procedure an electrical map is made so your doctor can see where the irregular signals are located in your heart. The electrical mapping system called AcQMap®. After creating the electrical map your doctor will perform an ablation, which is a procedure where the irregular signals are burned with an ablation catheter. The catheter, a long, thin tube that enters at an artery in your groin area and is directed to your heart. The end of the catheter is able to burn tissue on contact. Your physician will use this catheter to burn the areas in your heart where the irregular heart beats start. This study will collect data from just before your ablation up to 3 years.
The purpose of the study is to show that the FlexAbility™ SE Ablation Catheter is safe and effective in reducing the number of Ventricular Tachycardia (VT) episodes in patients who continue to experience VT despite taking antiarrhythmic medications (medicines to prevent abnormal heart rhythms), or who are unable to take antiarrhythmic medications. Subject should be at least 18 years old. The entire duration of the study will be one year from the ablation procedure and consists of four follow up visits after the ablation procedure.