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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorBiosense Webster, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

Diagnosed with paroxysmal or persistent Atrial Fibrillation (AF) or supraventricular tachycardia (SVT) or ventricular tachycardia (VT) and scheduled to undergo an ablation procedure for management of their arrhythmia with a per-protocol defined BW therapeutic catheter

Able and willing to comply with all pre, post and follow-up testing and requirements as per hospital standard of care

Signed patient informed consent form (ICF) as applicable per local regulation

Disqualifiers

Currently participating in an interventional (drug, device, biologic) clinical trial

Life expectancy of less than 12-months

Presenting any contraindication for the use of BWI commercially approved medical devices, as indicated in the respective user manuals

Trial design

Treatments tested in this trial

  • BWI Medical Device
  • Varipulse Catheter
  • Dual Energy THERMOCOOL SMARTTOUCH SF Catheter

Treatment groups

8,000 Participants
are divided into 1 treatment group

Locations

40
Austria
Medical University of Graz8010, Graz Austria
Ordensklinikum Linz GMBH4020, Linz Austria
NÖ Landesgesundheitsagentur3100, Sankt Pölten Austria
Belgium
OLV Aalst9300, Aalst Belgium

Sponsors and collaborators

Biosense Webster, Inc.

Lead sponsor