RecruitingOBSERVATIONAL

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

This study is gathering information on how well specific medical devices from Biosense Webster (BWI) work and how safe they are for people with heart rhythm problems. Doctors regularly use these devices during procedures to treat conditions like an irregular heartbeat. The study collects data during standard hospital care, meaning there are no new treatments or tests involved beyond what a patient would normally receive. The main goal is to confirm that these devices continue to be safe and effective for treating heart conditions and to gather more evidence for their use in improving patient health.

At a glance

Status

Recruiting

Sponsor

Biosense Webster, Inc.

Enrolment target

8,000

Start

22 Feb 2021

Estimated completion

31 Dec 2037

Arrhythmias, Cardiac

What is this study about?

This study is looking at how well and how safely certain medical devices work for people who have heart rhythm problems. Many people experience conditions where their heart beats too fast, too slow, or unevenly. Doctors often treat these issues with special procedures that use devices to help correct the heart’s rhythm. This study specifically focuses on devices made by a company called Biosense Webster Inc. (BWI).

The main idea behind this study is to observe how these devices are used in everyday hospital settings, when doctors are treating patients as they normally would. It's not testing new devices or new ways of treating patients; instead, it's collecting information on devices that are already approved and widely used. By doing this, the researchers can confirm that these devices remain safe and effective for patients with heart rhythm problems.

The information gathered will help doctors and medical professionals understand even more about these devices. It will build on the existing knowledge about how they improve heart health and can guide future treatment approaches for cardiac arrhythmias, which are simply different types of irregular heartbeats.

Key takeaways

This study observes how approved medical devices treat heart rhythm problems.
It helps confirm the safety and effectiveness of these devices in routine care.
No new treatments or extra procedures are involved beyond standard care.
Data collected will help improve future treatments for irregular heartbeats.
Participation depends on having a specific heart rhythm condition and scheduled procedure.

Who may be eligible?

To be part of this study, you would need to have certain heart rhythm problems, such as atrial fibrillation (an irregular and often rapid heartbeat), or other types of fast heartbeats like supraventricular tachycardia (SVT) or ventricular tachycardia (VT). You also need to be scheduled to have a specific type of procedure called an ablation, which uses a particular BWI device to help correct your heart rhythm.

You should also be able to attend all your scheduled appointments and follow the hospital's usual care instructions, both before and after your procedure. You'll also need to sign a consent form, which explains the study in detail and confirms you understand and agree to take part, as required by local rules.

You would not be able to join if you are currently taking part in another study that involves a new drug, device, or biological treatment. Also, if your doctor believes your life expectancy is less than 12 months, or if there's any reason listed in the device's user manual that makes it unsuitable for you to have a BWI device, then this study wouldn't be right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do you have an irregular heartbeat like atrial fibrillation or another fast heart rhythm?
Are you scheduled to have a heart ablation procedure using a BWI device?
Can you attend your regular follow-up appointments?
Are you currently not in another medical study using a new drug or device?
Do you have a life expectancy of more than 12 months?

Answer every question to see your result.

What does participation involve?

If you join this study, your participation will not involve any extra tests, appointments, or medications beyond what your doctor would normally recommend for your heart condition. You will undergo your scheduled heart rhythm procedure using one of the BWI medical devices, as your doctor plans. Researchers will simply collect information about how the device is used and how you are doing, as part of your standard medical care. This includes information from your pre-procedure assessments, during the procedure itself, and from your routine follow-up appointments. The total duration of your participation will depend on how long your doctor typically monitors patients after this type of procedure.

Potential risks and benefits

The potential benefits of this study include helping to confirm the safety and effectiveness of the medical devices already used in your care, which can improve treatments for others in the future. As this study only observes routine care, there are no additional treatments or procedures, so the risks are generally those associated with your standard medical procedure. You are free to withdraw from the study at any time without affecting your medical care.

Locations (39)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Medical University of Graz
Verified postcode
Graz, Austria· Recruiting
Ordensklinikum Linz GMBH
Verified postcode
Linz, Austria· Recruiting
NÖ Landesgesundheitsagentur
Verified postcode
Sankt Pölten, Austria· Recruiting
OLV Aalst
Verified postcode
Aalst, Belgium· Recruiting
AZ Sint-Jan Brugge
Verified postcode
Bruges, Belgium· Recruiting
CHU Saint-Pierre
Verified postcode
Brussels, Belgium· Recruiting
UZ Antwerp
Verified postcode
Edegem, Belgium· Recruiting
Jessa Hospital
Verified postcode
Hasselt, Belgium· Recruiting
UZ Brussels
Verified postcode
Jette, Belgium· Recruiting
ASBL CHU HELORA Hôpital de La Louvière site Jolimont
Verified postcode
La Louvière, Belgium· Recruiting
Aarhus University Hospital
Verified postcode
Aarhus, Denmark· Recruiting
Rigshospitalet
Verified postcode
Copenhagen, Denmark· Recruiting

Common questions

What is a 'heart rhythm problem'?

It's when your heart beats too fast, too slow, or with an irregular pattern instead of a steady rhythm.

Is this a new treatment?

No, this study looks at medical devices that are already approved and regularly used by doctors for heart rhythm problems.

Do I need extra appointments if I join?

No, you don't need any extra appointments. The study collects information during your normal hospital visits and procedures.

Who is Biosense Webster?

Biosense Webster is a company that makes medical devices, such as catheters, used in procedures to treat heart rhythm problems.

Can I leave the study at any time?

Yes, you have the right to withdraw from the study at any point without it affecting your medical care.

How to find out more

Nathalie Macours

nmacours1@its.jnj.com +32 479 97 05 05 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.