Observational Study on Safety and Performance of Biosense Webster Devices in Treating Cardiac Arrhythmias

What this Trial Is About

Researchers are collecting clinical data to evaluate the ongoing safety and performance of commercial Biosense Webster Inc. BWI medical devices used during routine cardiac arrhythmia mapping and ablation procedures. This observational study aims to confirm the safety and effectiveness of these devices after they have been approved for market use, expanding knowledge on their role in treating cardiac arrhythmias such as atrial fibrillation, supraventricular tachycardia, and ventricular tachycardia. Participants diagnosed with cardiac arrhythmias and scheduled for an ablation procedure using BWI therapeutic catheters, including Varipulse and Dual Energy THERMOCOOL SMARTTOUCH SF catheters, will be observed during their routine clinical treatment. The study does not introduce additional interventions but monitors standard procedures using these commercial devices. Sub-studies involve participants treated specifically with the Varipulse or Dual Energy catheters. During the study, participants will be monitored for adverse events related to the devices and procedures within 7 days post-procedure and up to one year for serious or non-serious adverse events. Effectiveness measures include arrhythmia isolation or elimination and freedom from arrhythmia episodes over time. Data collection aligns with routine care standards, including follow-up visits up to 365 days to assess outcomes such as arrhythmia recurrence, repeated ablations, hospitalizations, and mortality. The study duration extends through December 2037.

An Observational Post-marketing Study Using Commercially Approved Biosense Webster (BWI) Medical Devices for the Treatment of Participants With Cardiac Arrhythmias