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

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Health checks and monitoring — no treatment given
Type of study: Observational (no treatment given)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: BWI Medical Device (device), Varipulse Catheter (device), Dual Energy THERMOCOOL SMARTTOUCH SF Catheter (device)
How long the study runs: Study runs about 202 months (dates as stated)
About the drug or intervention: BWI Medical Device — device: Participants will be treated with commercially approved BWI medical devices following routine clinical practice. · Varipulse Catheter — device: Participants treated with Varipulse Catheter in the main study will be part of the VARIPURE sub-study. · Dual Energy THERMOCOOL SMARTTOUCH SF Catheter — device: Participants treated with the Dual Energy THERMOCOOL SMARTTOUCH SF Catheter in the main study will be part of the DUACURE sub-study.
Patient visit burden: Not specified by the sponsor

Type of study: Observing health over time
Ages: Not specified
Who: All
Number of participants: 8,000
Started: 2021-02-22
Last checked: 2026-09

Plain English Summary

What is this study?

• Testing a new treatment for arrhythmias, cardiac
• Clinical study - 8,000 participants
• 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

Who can take part?

• Adults
• Diagnosed with arrhythmias, cardiac

Where?

• Leicester - Glenfield Hospital
• London - St. Bartholomew's Hospital
• London - St George's Hospital
• London - Royal Brompton Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

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.

Arrhythmias, Cardiac

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: Not specified
Who can join: All genders

Who cannot take part

✗Currently participating in an interventional (drug, device, biologic) clinical trial
✗Life expectancy of less than 12-months
✗Presenting any safety concern for the use of BWI commercially approved medical devices, as indicated in the...

See the full 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

Where Is This Study? (4 UK sites)

Glenfield Hospital

Leicester LE3 9QP, United Kingdom

Recruiting

St. Bartholomew's Hospital

London EC1A 7BE, United Kingdom

COMPLETED

St George's Hospital

London SW17 0QT, United Kingdom

Recruiting

Hospital R&D contact (matched)

Mr Subhir Bedi

researchgovernance@sgul.ac.uk 020 8725 4986

Royal Brompton Hospital

London SW3 6NP, United Kingdom

Recruiting

Hospital R&D contact (matched)

Main Email: gstt.research.rbhh@nhs.net

gstt.research.rbhh@nhs.net n/a

How to Get in Touch

Nathalie Macours

Sponsor contact

CONTACT

+32 479 97 05 05 nmacours1@its.jnj.com

Liesbeth Gorissen

Sponsor contact

CONTACT

LGORISSE@ITS.JNJ.com

Data sourced from ClinicalTrials.gov · Last verified: 2026-09