A Prospective Single Center Pilot to Study Using the The CathVision ECGenius System to Collect Electrogram Data to Test an Ablation Impact Algorithm

Brief description of study

This study is being done to evaluate the safety and technical success of CathVision ECGenius® System to collect and record signals in your heart during electrophysiology (EP) procedures and test the performance of an ablation impact algorithm (software) for analyzing atrial fibrillation (AF) responses. Electrophysiology tests are performed to evaluate your hearts electrical activity and assist with diagnosing abnormal or irregular heartbeats. Electrophysiology. The researchers will collect information about your heart’s electrical activity during atrial fibrillation (AF) ablation procedures to test an algorithm for AF responses using a medical device called CathVision ECGenius® System. Atrial fibrillation ablation is a procedure that is performed to correct the heart rhythm and break up the electrical signals that cause irregular heartbeats. CathVision has developed an algorithm that analyzes information from the electrocardiogram (ECG, which measures the electrical activity of your heart) and the electric signaling in your heart and returns the analysis to the operator. In this way, the operator will be able to assess the impact of their ablation procedure.


Clinical Study Identifier: s22-00308


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