RecruitingNAINTERVENTIONAL

Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT) in Subjects With Uncontrolled Hypertension

This study, called SPYRAL SWYFT, is investigating a medical procedure known as renal denervation for people with high blood pressure that hasn't responded well to other treatments. The procedure involves using a special device called the Symplicity Spyral system to target nerves in the kidneys. The main goal is to find out if a more streamlined approach to this procedure, focusing on fewer areas in the kidney arteries, can still effectively lower blood pressure. Researchers also want to see if this simpler method is quicker to perform compared to previous techniques. This research could lead to a more efficient and effective way to help manage high blood pressure for many patients.

At a glance

Status

Recruiting

Phase

Sponsor

Medtronic Vascular

Enrolment target

130

Start

22 Sep 2025

Estimated completion

31 Dec 2029

Hypertension Vascular Diseases Cardiovascular Diseases Chronic Kidney Diseases Diabetes Mellitus

What is this study about?

This study, called SPYRAL SWYFT, is designed to help us better understand a treatment for high blood pressure that’s difficult to control. We know that conditions like cardiovascular diseases, chronic kidney disease, and diabetes can often be linked to high blood pressure, and finding effective treatments is really important.

The treatment being studied is called renal denervation. This procedure involves using a special device, called the Symplicity Spyral system, to gently disrupt nerves in the arteries of your kidneys. These nerves can play a role in keeping blood pressure high. Previous studies have looked at this treatment, and now researchers want to see if a slightly different way of performing the procedure – focusing on certain main and larger branch kidney arteries – is just as effective at lowering blood pressure. They also want to see if this new, more focused approach might make the procedure quicker to do.

Ultimately, the goal of this study is to ensure that if renal denervation becomes a common treatment, it’s done in the most effective and efficient way possible for patients. By refining the procedure, doctors hope to offer a valuable new option for those who struggle to get their blood pressure under control with other methods.

Key takeaways

Investigates a simpler approach to renal denervation for high blood pressure.
Aims to see if this new method is quicker and just as effective.
Could offer a new treatment option for difficult-to-control high blood pressure.
Studies the long-term safety and effectiveness of the Symplicity Spyral system.
Focuses on refining a procedure for better patient outcomes.

Who may be eligible?

To be able to take part in this study, participants generally need to have high blood pressure that is difficult to manage. This would typically mean their blood pressure readings are consistently above certain levels, both in the doctor's office and at home. They would also need to have had a specific type of blood pressure measurement over 24 hours, called an Ambulatory Blood Pressure Measurement, which confirms their high readings.

There are also some reasons why someone might not be able to join the study. For example, if your kidney arteries aren't suitable for the procedure, or if you've already had this type of kidney treatment before, you wouldn't be able to participate. Certain health conditions, such as severe kidney disease, a specific type of diabetes (Type 1), or active pregnancy or breastfeeding, would also mean you couldn't be included. The team will carefully check all these details to make sure the study is right and safe for you.

Quick self-check

Is your baseline blood pressure usually high, even with medication?
Do you have a recent 24-hour blood pressure recording showing high readings?
Have you been diagnosed with high blood pressure?
Have you ever had a similar kidney nerve treatment before? (If yes, you likely can't join)
Do you have severe kidney disease or Type 1 diabetes? (If yes, you likely can't join)
Are you pregnant, breastfeeding, or planning to become pregnant? (If yes, you likely can't join)

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

What does participation involve?

Taking part in this study would involve several visits to a clinic for assessments and the procedure itself. You would undergo blood pressure checks, including home monitoring and 24-hour measurements, and other health tests. The renal denervation procedure involves a small tube (catheter) being inserted into an artery, usually in your leg, and guided to your kidney arteries. The device then delivers gentle energy to the nerves. You'll have regular follow-up appointments over a long period to monitor your blood pressure and overall health after the procedure. The total duration of your participation, including all follow-ups, would be determined by the study protocol, ensuring long-term safety and effectiveness are monitored.

Potential risks and benefits

Potential benefits of participating could include a reduction in your blood pressure, which might lower your risk of serious health problems like heart attack or stroke. This procedure could offer a new treatment option if other methods haven't worked for you. However, as with any medical procedure, there are potential risks, such as bleeding or bruising at the insertion site, or very rarely, more serious complications. The study doctors will explain all potential risks in detail. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (19)

The Alfred Hospital
Melbourne, Australia· Recruiting
Royal Perth Hospital
Perth, Australia· Recruiting
Ziekenhuis Oost Limburg
Genk, Belgium· Recruiting
Algemeen Stedelijk Ziekenhuis - Campus Aalst
Aalst, Belgium· Recruiting
AZ Sint Jan Brugge-Oostende av
Bruges, Belgium· Recruiting
Universitair Ziekenhuis Gent
Ghent, Belgium· Recruiting
CHC MontLégia
Liège, Belgium· Recruiting
Universitat des Saarlandes
Homburg, Germany· Recruiting
Sana Kliniken Lübeck GmbH
Lübeck, Germany· Recruiting
Universitätsklinikum Erlangen
Erlangen, Germany· Recruiting
Leipzig Heart Institute
Leipzig, Germany· Recruiting
Schwarzwald-Baar Klinikum Villingen-Schwenningen
Villingen-Schwenningen, Germany· Recruiting

+7 more sites — see the official record for the full list.

Common questions

What is renal denervation?

It's a procedure where doctors use a special device to calm down overactive nerves in your kidney arteries that contribute to high blood pressure.

Why is this study important?

It helps find the most effective and efficient way to perform renal denervation, potentially offering a better treatment option for high blood pressure that's hard to control.

Will I need to change my current medications?

Medication changes would be discussed with your study doctor. The study aims to see how effective the procedure is, often alongside your usual medications.

Is the procedure painful?

You will be given anaesthesia, so you shouldn't feel pain during the procedure. Afterwards, you might experience some mild discomfort at the site where the small tube was inserted.

How long will I be involved in the study?

Participation involves initial assessments, the procedure, and then ongoing follow-up appointments over a period to check your blood pressure and health.

How to find out more

Kelsey Anderson

rs.spyralaffirm@medtronic.com 651 247 5268 Official trial record

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