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

Biosense Webster

Status: Enrolling

Conditions: Arrhythmias, Cardiac

Treatments: Device: BWI Medical Device; Device: Varipulse Catheter; Device: Dual Energy THERMOCOOL SMARTTOUCH SF Catheter

Study type: Observational

Funder types: Industry

Identifiers

NCT04750798

BWI_2019_05 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 8,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• 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

Exclusion criteria:

• 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

8,000 participants in 1 patient group

Participants Diagnosed with Cardiac Arrhythmias

Description:

Patients diagnosed with cardiac arrhythmias who are scheduled to undergo an ablation procedure in routine clinical practice for management of their arrhythmia with a BWI therapeutic catheter/Varipulse Catheter/ Dual Energy Thermocool Smarttouch surround flow (SF) catheter will be observed.

Treatment:

Device: Dual Energy THERMOCOOL SMARTTOUCH SF Catheter

Device: Varipulse Catheter

Device: BWI Medical Device