RecruitingOBSERVATIONAL

Global SYMPLICITY Registry (GSR) DEFINE

This study, called GSR DEFINE, is collecting information about a treatment for high blood pressure called renal denervation. It's not a typical trial where people get new medicines; instead, doctors are gathering details from many patients who are already having this procedure as part of their regular care. The main goal is to see how safe and well this treatment works over a long time – up to five years. By looking at thousands of patients worldwide, researchers hope to get a clear picture of its long-term effects. This will help doctors and patients understand more about using renal denervation for high blood pressure in real-life situations.

At a glance

Status

Recruiting

Sponsor

Medtronic Vascular

Enrolment target

5,000

Start

01 Feb 2012

Estimated completion

01 Dec 2031

Hypertension

What is this study about?

This study, called the Global SYMPLICITY Registry (GSR DEFINE), is all about understanding a treatment for high blood pressure called renal denervation. Instead of testing a new drug, this study collects information from patients who are already having this procedure as part of their normal care in hospitals around the world. Think of it like gathering lots of real-life experiences to learn more.

The main aim is to find out how safe and effective renal denervation is over a long period. Doctors want to see if it helps keep blood pressure down and if there are any side effects. They'll follow patients for at least a year, and some for up to five years, collecting details like blood pressure readings and any changes to their medication. This helps build a bigger picture of how the treatment works for different people in different places.

By including around 5,000 patients from many hospitals, the researchers hope to get a really good understanding of this treatment. This information is important because it helps improve our knowledge of how to manage high blood pressure and can guide doctors in making the best decisions for their patients.

Key takeaways

It's a study looking at a blood pressure treatment called renal denervation.
It collects data from real patients having the procedure in many hospitals.
The goal is to understand the long-term safety and effectiveness of the treatment.
No extra tests or treatments are involved beyond your usual care.
Your progress will be followed for up to 5 years.
Your participation helps improve knowledge for future patients.

Who may be eligible?

To be included in this study, you would generally need to be an adult, aged 18 or older. The decision to have renal denervation would be made by you and your doctor based on what's best for your health and according to the standard guidelines for using the Medtronic system.

It's important that you and your doctor have already decided that renal denervation is a suitable treatment for your high blood pressure. This study just collects information about how that treatment works for you, rather than being about deciding if you should have the procedure in the first place.

Finally, if you're deemed suitable and agree to join, you (or your legal representative) would need to sign a consent form. This form explains what information will be collected and how it will be used, making sure you're happy with everything before you participate.

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.

Are you 18 years old or older?
Has your doctor already decided that renal denervation is a suitable treatment for your high blood pressure?
Are you having the renal denervation procedure using a Medtronic device?
Are you willing to sign a form agreeing for your routine health data to be collected for research?

Answer every question to see your result.

What does participation involve?

If you take part in this registry, you won't have any extra treatments or tests just for the study. You will receive renal denervation as planned by your doctor as part of your usual care. The study simply collects information from your routine hospital visits and medical records. Researchers will look at things like your blood pressure readings, what medications you're taking, and general health information related to your high blood pressure. They'll follow your progress for at least one year and potentially up to five years after your procedure during your regular check-ups.

Potential risks and benefits

Taking part in this study doesn't involve any new medical procedures or medicines, so there are no direct extra risks beyond your standard care. The main benefit is that your health information will help doctors and researchers understand more about how well renal denervation works in the real world for people with high blood pressure, potentially helping future patients. You have the right to withdraw your consent and stop participating in the data collection at any time without it affecting your medical care.

Locations (2)

Universitätsklinikum des Saarlandes
Verified postcode
Homburg, Germany· Recruiting
Universitätsspital Basel
Verified postcode
Basel, Switzerland· Recruiting

Common questions

What is renal denervation?

It's a medical procedure for high blood pressure where tiny nerves around the kidneys are carefully treated to help lower blood pressure.

Is this a drug trial?

No, this is a registry study. It collects information about a specific procedure (renal denervation) that patients are already having as part of their routine care.

Will I get extra tests if I join?

No. All the information collected will come from your regular hospital visits and tests that are already planned for your treatment.

How long will they follow my health for?

Researchers will follow up on your health for at least one year, and possibly up to five years, after your procedure.

Will my personal details be shared?

No. Your information will be kept confidential, and your identity will be protected when the data is used for research.

How to find out more

K. Wandrey

rs.medtroniccardiovascularclinicaltrials@medtronic.com Official trial record

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