NCT04750798

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

An Observational Post-marketing Study for Evaluation of Ongoing Safety and Effectiveness of Catheter Mapping and Ablation Using Commercially Approved BWI Medical Devices for the Treatment of Patients With Cardiac Arrhythmias

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 8,000 (estimated)
• Sponsor: Biosense Webster, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to prospectively collect clinical data evaluating the ongoing safety and performance during routine-use standard cardiac arrhythmia mapping and/or ablation procedures while using commercial Biosense Webster Inc. (BWI) medical devices. Data generated from the study will be used to confirm safety and performance of BWI medical devices in the marketed phase and to expand the body of evidence on the use of these devices and techniques in treatment of cardiac arrhythmias.

Conditions

• Arrhythmias, Cardiac

Interventions

Type	Name	Description
DEVICE	BWI Medical Device	Participants will be treated with commercially approved BWI medical devices following routine clinical practice. No specific intervention will be observed for this study.
DEVICE	Varipulse Catheter	Participants treated with Varipulse Catheter in the main study will be part of the VARIPURE sub-study. No specific intervention will be observed for this study.
DEVICE	Dual Energy THERMOCOOL SMARTTOUCH SF Catheter	Participants treated with the Dual Energy THERMOCOOL SMARTTOUCH SF Catheter in the main study will be part of the DUACURE sub-study. No specific intervention will be observed for this study.

Timeline

• Start date: 2021-02-22
• Primary completion: 2036-12-31
• Completion: 2037-12-31
• First posted: 2021-02-11
• Last updated: 2026-04-13

Locations

39 sites across 13 countries: Austria, Belgium, Denmark, France, Germany, Ireland, Israel, Italy, Netherlands, Portugal, Sweden, Switzerland, United Kingdom

Regulatory

• FDA-regulated device study