The purpose of this study is to determine whether an investigational medical device called the Synaptic Cryoablation System is safe and effective for treating paroxysmal atrial fibrillation. Atrial fibrillation is an abnormal heart rhythm in which the upper chambers of the heart (the atria) beat very quickly and irregularly. When this happens, the atria cannot pump blood effectively. Participants will undergo an ablation procedure using the Synaptic Cryoablation System. Catheter ablation is often used to treat atrial fibrillation and involves placing catheters in the heart and delivering energy to destroy or isolate heart tissue that is thought to be responsible for the atrial fibrillation. The Synaptic Cryoablation System works by delivering energy to parts of the heart that are responsible for atrial fibrillation; it has been designed to create circular ablations using a balloon. Participants will also be asked to take a few non-invasive tests and record their heart rhythm at home.
What is the full name of this clinical trial?
Sensation: Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation with the Synaptic Compliant Cryoablation Balloon and System.