RecruitingOBSERVATIONAL

BoStOn SCientific Rhythm MAnagemenT REgiStry (SOCRATES)

The SOCRATES study, run by Boston Scientific, is a long-term project checking the safety and performance of their heart devices and related equipment in patients. This is a standard requirement for medical device companies in the UK and Europe. It involves collecting information from patients who have had these devices implanted or procedures using this equipment during their usual hospital visits. The study aims to gather ongoing data about how these products perform over their lifetime. It’s not testing new treatments, but rather observing existing ones. It will help ensure that these devices continue to meet high quality and safety standards for everyone.

At a glance

Status

Recruiting

Sponsor

Boston Scientific Corporation

Enrolment target

12,500

Start

31 Mar 2021

Estimated completion

31 Dec 2030

Cardiac Disease

What is this study about?

Imagine you have a new medical device, like a pacemaker, put into your body. While these devices go through rigorous testing before they're approved for use, it's also really important to see how they perform over many years in real-life situations. That's exactly what the SOCRATES study is for. Run by Boston Scientific, a company that makes these devices, this study helps them continuously monitor the safety and effectiveness of their heart-related products once they are being used by patients. This is a vital step required by health regulations in places like the UK and Europe, ensuring companies keep an eye on their products throughout their entire lifespan.

This study isn't about trying out new medicines or procedures; it's about observing how existing, approved devices and equipment are working. Doctors and medical teams will collect information from patients during their regular check-ups or follow-up appointments. This could include details about how the device is functioning, any issues that might arise, and how the patient is feeling overall. The main goal is to proactively gather, record, and analyse this information to make sure the devices continue to meet high quality and safety standards.

The SOCRATES study is designed to run continuously, meaning there isn't a set end date. This allows Boston Scientific to gather data over many years, potentially for the entire time a device is implanted. This long-term monitoring is crucial for understanding how devices perform over time, including things like battery life or long-term effectiveness, which helps improve future products and patient care.

Key takeaways

It's a safety and performance check of existing heart devices.
No extra appointments or changes to your medical care.
Your regular check-up information is used to monitor devices.
Helps ensure these devices are safe and effective long-term.
Participation is voluntary and you can withdraw anytime.

Who may be eligible?

You might be able to take part in this study if you are about to have a procedure involving a Boston Scientific heart device or related equipment, or if you had such a procedure very recently (within the last 10 days).

It's important that you are willing to give your permission for your health information to be collected and used for this study. If you're unable to give permission yourself, a legally designated representative might be able to do it for you, depending on local rules.

You might not be able to join if your doctors don't expect you to continue your follow-up appointments at the same hospital or clinic for at least a year after getting an implant, or for at least a month after a procedure involving heart equipment. Also, if you're receiving a treatment or device that isn't yet fully approved for general use, you wouldn't be eligible for this study.

Quick self-check

Are you about to have, or have you recently had (within 10 days), a procedure using a Boston Scientific heart device or equipment?
Are you able to agree to your health information being used for this study, or can a legal representative do so for you?
Do you expect to continue your follow-up appointments at the same clinic for at least a year (for implants) or a month (for other procedures)?
Is the device or treatment you're receiving already approved for general use?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in the SOCRATES study, it mainly involves your healthcare team collecting information during your regular hospital or clinic visits and check-ups. You won't have any extra appointments or receive any different treatments specifically because of the study. You will continue to receive your standard care and follow-up as advised by your doctor for your heart condition.

The duration of your participation in the study usually depends on the specific device you have and how long it's expected to be in use. For some implanted devices, you might be followed for as long as the device is in your body. For other procedures, it could be for a shorter period, perhaps a few months to a year, to properly assess how the device performed. The total length of your involvement will be clearly explained to you if you are considering joining.

Potential risks and benefits

Participating in this study involves no changes to your medical treatment or care, so there are no direct extra risks beyond those associated with your usual medical procedures or having an implanted device. The main benefit is that by allowing your de-identified medical information to be collected, you're contributing to a larger effort to ensure the long-term safety and effectiveness of heart devices for current and future patients in the UK and globally. You have the right to withdraw from the study at any time without it affecting your medical care.

Locations (26)

Universitair Ziekenhuis Brussel
Jette, Belgium· Recruiting
CHU UCL Namur - Site Godinne
Yvoir, Belgium· Recruiting
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Québec, Canada· Recruiting
CHRU de Brest, Hôpital de la Cavale Blanche
Brest, France· Recruiting
CHRU de Clermont-Ferrand
Clermont-Ferrand, France· Recruiting
Hopital Saint Philibert
Lomme, France· Recruiting
CHG de Pau
Pau, France· Recruiting
CHU de Saint-Etienne
Saint-Etienne, France· Recruiting
Unfallkrankenhaus Berlin Marzahn
Berlin, Germany· Recruiting
Augusta Kranken Anstalt GmbH
Bochum, Germany· Completed
General Hospital of Athens "G. Gennimatas"
Athens, Greece· Completed
Onassis Cardiac Surgery Center
Athens, Greece· Recruiting

+14 more sites — see the official record for the full list.

Common questions

What is the SOCRATES study looking at?

It's observing how Boston Scientific's heart devices and equipment perform in real patients over time, to ensure their safety and effectiveness.

Do I have to do anything extra if I join?

No, you don't. Your doctors will collect information during your regular check-ups; you won't have any additional appointments or treatments just for the study.

Will my care change if I participate?

No, your medical care and treatment will remain exactly the same whether you join the study or not.

How long would I be part of the study?

It varies, depending on the type of device you have. For some implanted devices, it could be for many years, for others, it might be shorter, like a few months or a year.

Can I leave the study if I change my mind?

Yes, you can withdraw your permission for your data to be used at any time, and it will not affect your medical care.

How to find out more

Maria Paz Lopez-Chicharro

maria.lopez-chicharro@bsci.com 1-800-227-3422 Official trial record

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