Evaluating the Dual Energy THERMOCOOL SMARTTOUCH SF Catheter with TRUPULSE Generator for Treating Ventricular Arrhythmias Using a Specific Procedural Workflow

What This Trial Is About

Researchers are evaluating the safety and effectiveness of the Dual Energy THERMOCOOL SMARTTOUCH SF DE STSF catheter used with the TRUPULSE generator for treating ventricular arrhythmias, which are abnormal heart rhythms. This study focuses on whether the catheter and generator system can successfully treat these arrhythmias while following a specific procedural workflow during cardiac ablation. Participant safety is also closely monitored after the procedure to check for any complications. Participants with premature ventricular complexes PVC, sustained monomorphic ischemic ventricular tachycardia SMIVT, or sustained monomorphic non-ischemic ventricular tachycardia SMNIVT will undergo catheter ablation using the DE STSF catheter and TRUPULSE generator. The treatment involves delivering radiofrequency and pulsed field energy primarily as stacking applications, following the studys procedural workflow. This is a single-group interventional study assessing the catheter and generator combination. During the study, participants will be monitored for effectiveness at 3 months for PVC and at 6 months for SMIVT and SMNIVT after the ablation procedure. Safety monitoring includes checking for primary adverse events up to 7 days post-procedure and serious adverse device effects and other adverse events up to 6 months. Various intraoperative measurements such as procedure time, mapping, ablation parameters, and anesthesia type will also be recorded. Overall, participants will be followed until the primary completion date, which is up to about 15 months from study start.

A Study of Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter With the TRUPULSE™ Generator for Treatment of Ventricular Arrhythmias