Evaluation of 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 catheter combined with the TRUPULSE generator for treating ventricular arrhythmias. This study focuses on whether the abnormal heart rhythms, including premature ventricular complexes and sustained monomorphic ventricular tachycardias, can be successfully treated using a specific procedural workflow during cardiac ablation. The trial also monitors participant safety by checking for any complications after the procedure. Participants undergo catheter ablation using the Dual Energy THERMOCOOL SMARTTOUCH SF catheter with the TRUPULSE generator, which delivers radiofrequency and pulsed field energy mainly as RFPF stacking applications according to the studys procedural workflow. The study groups include those being treated for premature ventricular complexes and different types of sustained ventricular tachycardia. The study tracks the procedures effectiveness and safety over several months following the ablation. During the study, participants are monitored with assessments including electrocardiographic data review, tracking of adverse events up to six months post-procedure, and intraoperative measurements such as procedure time, mapping details, and ablation parameters. Researchers measure the success of the procedural workflow at 3 months for premature ventricular complexes and at 6 months for ventricular tachycardia cases. Safety is closely observed up to 7 days and 6 months after the ablation to detect any adverse effects or complications.

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