Evaluation of VISITAG SURPOINT™ Module with External Processing Unit when used with the THERMOCOOL SMARTTOUCH® SF and the THERMOCOOL SMARTTOUCH® catheters for Pulmonary Vein Isolation (PVI) (SURPOINT COA)

Brief description of study

The purpose of this study is to assess the safety and effectiveness (how well something works) of Tag Index-guided ablation for the treatment of Paroxysmal Atrial Fibrillation (PAF). AF is caused by abnormal electrical signals in the upper chambers of the heart, called the atria, which cause them to beat rapidly and irregularly. When the atria beat rapidly and irregularly they do not pump blood effectively. Although this is usually not a life-threatening condition, AF can affect the health and quality of life in many ways. People may experience palpitations, chronic fatigue and weakness, shortness of breath, and pain. In addition, the risk for stroke may be higher. The purpose of this study is to provide additional information about the safety and effectiveness of the VISITAG SURPOINT™ Module with External Processing Unit (EPU) when used with a THERMOCOOL SMARTTOUCH® SF (STSF) and THERMOCOOL SMARTTOUCH® (ST) catheter, in the treatment of PAF.

Clinical Study Identifier: s18-01078
ClinicalTrials.gov Identifier: NCT03624881
Principal Investigator: Larry A Chinitz
Currently Recruiting

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