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8,000-Patient study monitors Real-World safety of heart rhythm devices

NCT ID NCT04750798

Knowledge-focused Sponsor: Biosense Webster, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This observational study will follow 8,000 people with irregular heartbeats (arrhythmias) who are scheduled for a standard catheter ablation procedure using Biosense Webster devices. Researchers will track safety issues and how well the procedure works in everyday hospital practice. The goal is to confirm the devices perform as expected outside of controlled clinical trials.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study will confirm that these devices are safe and effective in everyday use, supporting their continued use for treating irregular heartbeats.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by differences in patient care. It does not test a new treatment, only monitors existing ones.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 8,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2021

Expected to finish

Dec 2037

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Study population consists of participants diagnosed with cardiac arrhythmias who are scheduled to undergo an ablation procedure for management of their arrhythmia with a per-protocol defined Biosense Webster Inc (BWI) therapeutic catheter.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Arrhythmias, Cardiac atrial fibrillation cardiac rhythm disease ventricular tachycardia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Arrhythmias, cardiac Cardiac arrhythmias

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    38 sites in 14 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • ASBL CHU HELORA Hôpital de La Louvière site Jolimont

    RECRUITING

    La Louvière, 7100, Belgium

  • AZ Sint-Jan Brugge

    RECRUITING

    Bruges, 8000, Belgium

  • Aarhus University Hospital

    RECRUITING

    Aarhus, 8200, Denmark

  • Alfried Krupp Hospital

    RECRUITING

    Essen, 45131, Germany

  • Asklepios Klinik Altona

    RECRUITING

    Hamburg, 22763, Germany

  • CHU Saint-Pierre

    RECRUITING

    Brussels, 1000, Belgium

  • Cardioangiologisches Centrum Bethanien (CCB)

    COMPLETED

    Frankfurt, 60431, Germany

  • Centre Hospitalier Universitaire de Bordeaux

    RECRUITING

    Talence, 33404, France

  • Clinica Mediterranea

    RECRUITING

    Naples, 80122, Italy

  • Clinical Trial Center Maastricht

    RECRUITING

    Maastricht, 6229 EV, Netherlands

  • Erasmus University Medical Center

    RECRUITING

    Rotterdam, 3015 GD, Netherlands

  • German Heart Centre Munich

    RECRUITING

    Munich, 80636, Germany

  • Glenfield Hospital

    RECRUITING

    Leicester, LE3 9QP, United Kingdom

  • Herz- und Diabeteszentrum NRW, University Hospital of the Ruhr University Bochum

    RECRUITING

    Bad Oeynhausen, 3245, Germany

  • Hospital de Santa Cruz

    RECRUITING

    Carnaxide, 2790-134, Portugal

  • Hôpital Saint Joseph de Marseille

    RECRUITING

    Marseille, 13285, France

  • INSELSPITAL Universitätsspital Bern

    RECRUITING

    Bern, 03010, Switzerland

  • IRCCS Policlinico San Donato

    RECRUITING

    Milan, 20097, Italy

  • Institut Mutualiste Montsouris

    RECRUITING

    Paris, 75674, France

  • Jessa Hospital

    RECRUITING

    Hasselt, 3500, Belgium

  • Justus-Liebig-University Giessen

    RECRUITING

    Giessen, 35390, Germany

  • Les Hospices Civils de Lyon

    RECRUITING

    Lyon, 69002, France

  • Les Hôpitaux Universitaires de Strasbourg

    RECRUITING

    Strasbourg, 67000, France

  • Mater Private Heart and Vascular Centre

    RECRUITING

    Dublin, D07 WKW8, Ireland

  • Medical University of Graz

    RECRUITING

    Graz, 8010, Austria

  • OLV Aalst

    RECRUITING

    Aalst, 9300, Belgium

  • Ordensklinikum Linz GMBH

    RECRUITING

    Linz, 4020, Austria

  • Ospedale Generale Regionale "F. Miulli"

    RECRUITING

    Acquaviva delle Fonti, 70021, Italy

  • Rhön-Klinikum Campus Bad Neustadt

    RECRUITING

    Bad Neustadt an der Saale, 97616, Germany

  • Rigshospitalet

    RECRUITING

    Copenhagen, 2100, Denmark

  • Royal Brompton Hospital

    RECRUITING

    London, SW3 6NP, United Kingdom

  • Sahlgrenska University Hospital

    RECRUITING

    Gothenburg, 413 45, Sweden

  • Segeberger Kliniken

    RECRUITING

    Bad Segeberg, 23795, Germany

  • Semmelweis University

    RECRUITING

    Budapest, H-1085, Hungary

  • Shaare Zedek Medical Center

    RECRUITING

    Jerusalem, 9103102, Israel

  • St George's Hospital

    RECRUITING

    London, SW17 0QT, United Kingdom

  • St. Bartholomew's Hospital

    COMPLETED

    London, EC1A 7BE, United Kingdom

  • Tel Aviv Sourasky Medical Center

    COMPLETED

    Tel Aviv, 6423906, Israel

  • UZ Antwerp

    RECRUITING

    Edegem, 2650, Belgium

  • UZ Brussels

    RECRUITING

    Jette, 1090, Belgium

  • Universitätsklinikum Wiener Neustadt

    RECRUITING

    Wiener Neustadt, 2700, Austria

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